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Sunscreen Agents (Topical)

This monograph includes information on the following:

1) Aminobenzoic Acid, Padimate O, and Oxybenzone ^*
2) Aminobenzoic Acid and Titanium Dioxide ^†
3) Avobenzone, Octocrylene, Octyl Salicylate, and Oxybenzone ^*
4) Avobenzone and Octyl Methoxycinnamate ^*
5) Avobenzone, Octyl Methoxycinnamate, Octyl Salicylate, and Oxybenzone ^*
6) Avobenzone, Octyl Methoxycinnamate, and Oxybenzone
7) Dioxybenzone, Oxybenzone, and Padimate O ^†
8) Homosalate
9) Homosalate, Menthyl Anthranilate, and Octyl Methoxycinnamate ^†
10) Homosalate, Menthyl Anthranilate, Octyl Methoxycinnamate, Octyl Salicylate, and Oxybenzone
11) Homosalate, Octocrylene, Octyl Methoxycinnamate, and Oxybenzone ^*
12) Homosalate, Octyl Methoxycinnamate, Octyl Salicylate, and Oxybenzone
13) Homosalate, Octyl Methoxycinnamate, and Oxybenzone ^†
14) Homosalate and Oxybenzone ^†
15) Lisadimate, Oxybenzone, and Padimate O ^†
16) Lisadimate and Padimate O ^†
17) Menthyl Anthranilate ^†
18) Menthyl Anthranilate, Octocrylene, and Octyl Methoxycinnamate ^†
19) Menthyl Anthranilate, Octocrylene, Octyl Methoxycinnamate, and Oxybenzone ^†
20) Menthyl Anthranilate and Octyl Methoxycinnamate ^†
21) Menthyl Anthranilate, Octyl Methoxycinnamate, and Octyl Salicylate ^†
22) Menthyl Anthranilate, Octyl Methoxycinnamate, Octyl Salicylate, and Oxybenzone ^†
23) Menthyl Anthranilate, Octyl Methoxycinnamate, and Oxybenzone ^†
24) Menthyl Anthranilate and Padimate O ^*
25) Menthyl Anthranilate and Titanium Dioxide ^†
26) Octocrylene and Octyl Methoxycinnamate
27) Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, and Oxybenzone
28) Octocrylene, Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone, and Titanium Dioxide ^†
29) Octocrylene, Octyl Methoxycinnamate, and Oxybenzone
30) Octocrylene, Octyl Methoxycinnamate, Oxybenzone, and Titanium Dioxide
31) Octocrylene, Octyl Methoxycinnamate, and Titanium Dioxide
32) Octyl Methoxycinnamate
33) Octyl Methoxycinnamate and Octyl Salicylate
34) Octyl Methoxycinnamate, Octyl Salicylate, and Oxybenzone
35) Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone, and Padimate O
36) Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone, Padimate O, and Titanium Dioxide ^†
37) Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone, Phenylbenzimidazole, and Titanium Dioxide ^†
38) Octyl Methoxycinnamate, Octyl Salicylate, Oxybenzone, and Titanium Dioxide
39) Octyl Methoxycinnamate, Octyl Salicylate, Phenylbenzimidazole, and Titanium Dioxide ^†
40) Octyl Methoxycinnamate, Octyl Salicylate, and Titanium Dioxide
41) Octyl Methoxycinnamate and Oxybenzone
42) Octyl Methoxycinnamate, Oxybenzone, and Padimate O ^†
43) Octyl Methoxycinnamate, Oxybenzone, Padimate O, and Titanium Dioxide ^*
44) Octyl Methoxycinnamate, Oxybenzone, and Titanium Dioxide ^†
45) Octyl Methoxycinnamate and Padimate O ^†
46) Octyl Methoxycinnamate and Phenylbenzimidazole
47) Octyl Salicylate ^†
48) Octyl Salicylate and Padimate O ^†
49) Oxybenzone and Padimate O
50) Oxybenzone and Roxadimate ^*
51) Padimate O ^†
52) Phenylbenzimidazole
53) Phenylbenzimidazole and Sulisobenzone ^†
54) Titanium Dioxide ^†
55) Titanium Dioxide and Zinc Oxide
56) Trolamine Salicylate ^†

INN:
Octocrylene— Octocrilene
^{53}
VA CLASSIFICATION
Primary: DE300

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

^*Not commercially available in the U.S.

^†Not commercially available in Canada.

Category:

Skin protectant (topical)—

Indications

General considerations
The degree of protection provided by a sunscreen product may be determined by the following: the sunscreen protection factor (SPF), which evaluates ultraviolet B (UVB) light-blocking capacity; phototoxic protection factor (or other protection factors), which evaluates ultraviolet A (UVA) light-blocking activity; and substantivity.

UVB light is known as the ``sunburn ray'' because of its tendency to cause erythema of the skin. A sunscreen agent should be effective in reducing erythema due to sun exposure. The SPF displayed on sunscreen agent containers is a measure of the amount of UVB light needed to produce a minimal erythema reaction in sunscreen-protected skin compared with unprotected skin. Sunscreen agents with SPF of 15 or greater are considered sunblocks because they may absorb more than 92% of UVB radiation. ^{01} ^{03}

UVA light may also induce erythema but at considerably higher doses than UVB light. Currently, there is no standard method to assess sunscreen agents for UVA protection. Difficulty in determining UVA protection may be due to the extremely long exposure time to UVA needed to produce erythema ^{154}. One method utilizes the phototoxic protection factor (this is not usually required in the labeling of sunscreen products) ^{87} ^{154}, which represents the amount of UVA light needed to produce a minimal phototoxic response in sunscreen-protected photosensitized skin compared with unprotected photosensitized skin. ^{01} ^{02} ^{03}

Substantivity is defined as the sunscreen's resistance to removal by physical means, such as being washed off by water or by sweating. The substantivity of sunscreen agents is determined by the design of the vehicle and the active ingredients. Sweat resistance is determined by measuring the SPF after 30 minutes on a person who is sweating profusely. ``Water-resistant'' and ``waterproof'' sunscreens are determined by measuring the SPFs after water exposures of 40 and 80 minutes, respectively. ^{01} ^{03}

Accepted

Sunburn (prophylaxis)—Sunscreen agents are indicated for the prevention of sunburn. In addition to limiting the skin's exposure to the sun, using sunscreen agents regularly when in the sun may help reduce long-term sun damage such as premature aging of the skin and skin cancer. ^{05} ^{10} ^{13} ^{15} ^{43} ^{46} ^{55} ^{82} ^{128} ^{151}

Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical sunscreens

Aminobenzoic acid and derivatives
    Aminobenzoic acid (p-aminobenzoic acid or PABA) ^{43} ^{46} ^{52}
    Lisadimate (glyceryl PABA) ^{43} ^{46} ^{52}
    Padimate O (octyldimethyl PABA ^{43} ^{46} ^{52} ^{53})
    Roxadimate (ethyl 4-bis [hydroxypropyl] aminobenzoate) ^{43} ^{46}

Anthranilates
    Menthyl anthranilate ^{46}

Benzophenones
    Dioxybenzone (Benzophenone-8) ^{05} ^{43} ^{46} ^{53}
    Oxybenzone (Benzophenone-3) ^{05} ^{43} ^{46}
    Sulisobenzone (Benzophenone-4) ^{33}

Cinnamates
    Octocrylene (2-ethylhexyl-2-cyano-3,3-diphenylacrylate) ^{46}
    Octyl methoxycinnamate (2-ethylhexyl p-methoxycinnamate ^{07} ^{43} ^{46})

Dibenzoylmethanes
    Avobenzone (t-butyl dimethoxydibenzoylmethane) ^{07} ^{46} ^{53}

Salicylates
    Homosalate (homomenthyl salicylate ^{07} ^{43} ^{46})
    Octyl salicylate (2-ethylhexyl salicylate) ^{07} ^{43} ^{46}
    Trolamine salicylate (Triethanolamine salicylate) ^{43}

Miscellaneous
    Phenylbenzimidazole (2-Phenylbenzimidazole-5-sulfonic acid) ^{43}

Physical sunscreens
    Titanium dioxide ^{43} ^{46}
    Zinc oxide ^{43} ^{46}
Molecular weight—
    Aminobenzoic acid: 137.14 ^{53} ^{159}
    Avobenzone: 310.40 ^{159}
    Dioxybenzone: 244.25 ^{53} ^{159}
    Homosalate: 262.35 ^{53} ^{159}
    Lisadimate: 211.22 ^{53} ^{159}
    Menthyl anthranilate: 151.16 ^{53}
    Octocrylene: 361.49 ^{159}
    Octyl methoxycinnamate: 290.40 ^{53}
    Octyl salicylate: 250 ^{52}
    Oxybenzone: 228.25 ^{53} ^{159}
    Padimate O: 277.41 ^{53} ^{159}
    Phenylbenzimidazole sulfonic acid: 274 ^{52}
    Roxadimate: 281.35 ^{53} ^{159}
    Sulisobenzone: 308.31 ^{53} ^{159}
    Titanium dioxide: 79.88 ^{53} ^{159}
    Trolamine salicylate: 287 ^{52}
    Zinc oxide: 81.39 ^{53} ^{159}

Mechanism of action/Effect:

Chemical sunscreen agents—Diminish the penetration of ultraviolet (UV) light through the epidermis by absorbing UV radiation within a specific wavelength range. ^{03} ^{05} The amount and wavelength of UV radiation absorbed are affected by the molecular structure of the sunscreen agent. ^{01} ^{03}

Physical sunscreen agents—Minimize UV penetration through the epidermis by creating a physical barrier that reflects, scatters, ^{01} ^{02} ^{03} ^{35} absorbs, ^{154} ^{155} and blocks UV and visible radiations. ^{01} ^{02} ^{03} ^{35}

Table 1. Pharmacology

Sunscreen Agents	Drug	Concentration (%)	Absorbance Wavelength nanometer (nm)
Absorbers ¹ ^{01} ^{02} ^{05} ^{07} ^{33} ^{46}	Avobenzone	3	320–400
	Dioxybenzone	3	250–390
	Menthyl anthranilate	3.5–5	260–380
	Oxybenzone	2–6	270–350
	Sulisobenzone	5–10	260–375
Absorbers ² ^{01} ^{02} ^{05} ^{07} ^{33} ^{46}	Aminobenzoic acid	5–15	260–313
	Homosalate	4–15	295–315
	Lisadimate	2–3	264–315
	Octocrylene	7–10	250–360
	Octyl methoxycinnamate	2–7.5	290–320
	Octyl salicylate	3–5	280–320
	Padimate O	1.4–8	290–315
	2-Phenylbenzimidazole-5-sulfonic acid	1–4	290–340
	Roxadimate	1–5	280–330
	Trolamine salicylate	5–12	260–320
Physical	Titanium dioxide	2–25	290–700
blockers ^{01} ^{02} ^{05} ^{07} ^{33} ^{46}	Zinc oxide		290-700

¹ FDA-proposed UVA protection defined as absorption spectrum ³360 nm.
² FDA-approved UVB protection defined as absorption spectrum 290–320 nm.

Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to artificial sweeteners (e.g., saccharin, sodium cyclamate) ^{22} ^{33}; ester-type anesthetics (e.g., benzocaine, procaine, tetracaine) ^{01} ^{33} ^{34}; para-amino type azo dyes (e.g., aniline, paraphenylenediamine) ^{01} ^{33}; sulfonamide antibiotics ^{01} ^{33} ^{34}; sulfonamide-based oral hypoglycemics ^{33}; or thiazide diuretics ^{01} ^{33} ^{34} may be sensitive to sunscreen agents containing aminobenzoic acid (PABA) or its derivatives. ^{07}

Patients sensitive to cinnamon derivatives (balsam of Peru, balsam of Tolu, Cassia, cinnamic acid, cinnamic alcohol, cinnamic aldehyde, cinnamon oil, coca leaves), which are used in cosmetics and perfumes and as flavoring agents in medications and toothpastes, may be sensitive to cinnamate-containing sunscreen agents. ^{05}

Cross-sensitivity may occur among sunscreens ^{35} containing benzophenone ^{28}, dibenzoylmethane ^{35} ^{52}, and aminobenzoic acid or its derivatives.

Carcinogenicity

Studies of the nitrosamine, N-methyl-N-nitrosaminobenzoate octyl ester (NMPABAO), found in minute quantities in sunscreen agents containing padimate O, have shown that NMPABAO does not have carcinogenic potential. However, these results have not been verified with a carcinogenic bioassay. NMPABAO rapidly decomposes when exposed to UV radiation. ^{01} ^{45} ^{48}

There are no reports of carcinogenic potential for other sunscreen agents.

Mutagenicity

Studies of the nitrosamine N-methyl-N-nitrosaminobenzoate octyl ester (NMPABAO) found in sunscreen agents containing padimate O have not shown any mutagenic potential. ^{48}

There are no reports of mutagenic potential for other sunscreen agents.

Pregnancy/Reproduction

Problems in humans have not been documented. ^{152}

Breast-feeding

Problems in humans have not been documented. ^{152}

Pediatrics

Sun protection for children is very important. Studies show the risk of developing skin cancer is increased by excessive exposure to the sun during childhood. It is reported also that in cutaneous melanoma a large proportion of skin damage caused by the sun has been acquired during the first 10 to 20 years of life. ^{52} Furthermore, the regular use of a sunscreen with a sun protection factor (SPF) of 15 during the first 18 years of life may help reduce the lifetime incidence of nonmelanoma skin cancer by about 75%, if children using sunscreens do not stay out in the sun longer than they would have if sunscreens had not been used. ^{45} ^{155}

Infants under 6 months of age should be kept out of the sun and be physically protected from direct sun exposure. ^{48} Sunscreen agents should not be used on infants under 6 months of age ^{02} ^{14} because of possible irritation and accidental ingestion. ^{43} ^{46} ^{47} ^{155}

Children 6 months of age and older should not be exposed or should receive only moderate exposure to the sun and should be protected by sunscreen agents with SPF of 15 or higher when in the sun. ^{13} ^{14} ^{45} ^{47} ^{152} Lotion sunscreen products are preferred for use in children. Alcohol-based sunscreen products should be avoided because they can cause irritation. ^{32} ^{33}

Geriatrics

Studies have suggested a possibility that frequent use of sunscreen agents may put the population, especially the elderly who spend little time in the sun, at risk of vitamin D deficiency, ^{156} ^{157} which could lead to osteomalacia, osteoporosis, or bone fractures. ^{12} ^{51} However, a recent study failed to confirm this finding. ^{158} Oral vitamin D supplementation in addition to adequate food intake rich in vitamin D may be advisable for the elderly. ^{01} ^{12} ^{49} ^{50}

Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

Risk-benefit should be considered when the following medical problems exist
Photodermatoses, such as
Dermatitis, atopic, or chronic actinic, or seborrheic or
Herpes labialis or
Lichen rubeo planus or
Lupus erythematosus or
Persistent light reaction or
Photosensitivity, idiopathic, or musk ambrette or
Phytophotodermatitis or
Polymorphous light eruption or
Xeroderma pigmentosum (use of sunscreen agents may aggravate these conditions due to increased sensitivity of the skin to the chemicals; ^{09} ^{16} ^{17} ^{18} ^{21} ^{23} ^{25} ^{27} ^{28} ^{33} ^{35} patch testing before use may be advisable ^{153})

Sensitivity to the sunscreen or other ingredients of the preparation^{19}^{21}^{26}^{29}^{30}^{31}^{32}^{36}^{37}^{38}^{39}^{40}^{41}^{42}^{44}^{52}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Patch and photopatch tests (may be required prior to use of sunscreen agents for patients with photodermatoses to avoid sunscreen-induced allergic reactions ^{27} if potential for such reactions is suspected clinically ^{155})

Side/Adverse Effects

Note: The reported incidence of side effects due to sunscreen use is less than 1 to 2%. All sunscreen agents have been reported to cause allergic reactions but the frequency of such reactions is low. Irritation due to the vehicle rather than to the sunscreen's active ingredient seems to be the frequent cause of adverse effects. ^{02} ^{19} ^{35} ^{43} ^{155}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare

Acne ^{29}^{46}

allergic contact dermatitis (burning, itching, or stinging of skin)^{02}^{19}

folliculitis (burning, itching, and pain in hairy areas; pus in hair follicles)^{29}^{34}^{46}

photoallergic contact dermatitis (early appearance of redness or swelling of the skin; late appearance of rash with or without weeping blisters that become crusted, especially in sun-exposed areas of skin, and that may extend to unexposed areas)^{04}^{21}^{22}^{23}^{24}^{25}^{26}^{27}^{29}^{30}^{34}^{35}^{36}^{40}^{42}^{44}^{52}

skin irritation (burning, itching, redness, or stinging of skin)^{19}^{35}

skin rash^{07}^{29}^{34}^{46}

Note: Acne, folliculitis, or skin rash may occur with physical sunscreen agents because of their occlusive property. ^{29} ^{46}

Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent

Drying, stinging, or tightening of skin —may occur with alcohol-based sunscreen agents^{07}

Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Sunscreen Agents (Topical).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this product
»   Conditions affecting use, especially:
Sensitivity to the sunscreen agents or excipients in the formulation, artificial sweeteners, ester-type anesthetics, para-amino type azo dyes, sulfonamide antibiotics, sulfonamide-based oral hypoglycemics, thiazide diuretics, and cinnamon derivatives ^{01} ^{09} ^{21} ^{33} ^{34} ^{35}

Use in children—Not recommended for use in children under 6 months of age because of possible irritation and accidental ingestion; ^{43} ^{46} ^{47} ^{155} keeping children 6 months of age and older out of the sun or moderating their exposure to the sun and using sunscreen agents with a sun protection factor (SPF) of 15 or higher during exposure ^{13} ^{14} ^{45} ^{47} ^{152}; using lotion sunscreen products for children; avoiding use of alcohol-based sunscreen products because of their potential for causing irritation ^{32} ^{33}

Use in the elderly—Believed to put the elderly, who spend little time in the sun and use sunscreens frequently, at risk for vitamin D deficiency, although this has not been proven; ^{156} ^{157} eating a diet including food rich in vitamin D; taking oral vitamin D supplements as recommended by physician ^{01} ^{12} ^{49} ^{50}

Proper use of this product
For external use only; reading directions carefully before using any product ^{48} ^{57} ^{58} ^{59} ^{60}

» Taking the following into consideration when choosing sunscreen agents: type of activity, age, site of application, skin condition, and skin type ^{33} ^{48}

» Before every exposure to the sun, applying an appropriate sunscreen agent that protects against ultraviolet radiation; for maximum protection, applying uniformly and thickly to all exposed skin surfaces, including lips (using lip balm or lip sunscreen); applying sunscreen products containing aminobenzoic acid or its derivatives 1 to 2 hours before sun exposure; applying other sunscreen products 30 minutes before sun exposure, unless otherwise directed by the package instructions

Reapplying liberally and frequently (every 1 to 2 hours for adequate protection), especially after swimming or heavy perspiration; for lip sunscreen, reapplying liberally at least once every hour while in the sun, before and after swimming, after eating and drinking, and during activities that remove it from the lips

» Avoiding contact with eyes ^{48} ^{56} ^{57} ^{58} ^{59} ^{60}

» Not using alcohol-based sunscreen agents near heat, near open flame, or while smoking ^{20} ^{60}

» Proper dosing

» Proper storage

Precautions while using this product
Discontinuing use and checking with physician if rash or irritation develops ^{48} ^{57} ^{58} ^{60}

Sunscreen agents containing aminobenzoic acid or its derivatives may discolor and stain light-colored fabrics yellow ^{01} ^{32}

» In addition to using sunscreen agents, minimizing exposure to the sun from 10 a.m. to 2 p.m. (11 a.m. to 3 p.m. daylight savings time); ^{01} ^{47} ^{52} ^{54} taking extra precautions also on cloudy or overcast days and around reflective surfaces such as concrete, sand, snow, or water; wearing protective clothing including a hat, long-sleeved shirt, and long pants; wearing sunglasses; ^{47} avoiding sunlamps ^{11} ^{13} ^{47} and tanning parlors ^{03} ^{13} ^{14} ^{43} ^{47}

Side/adverse effects
Signs of potential side effects, especially acne; allergic contact dermatitis; folliculitis; photoallergic contact dermatitis; skin irritation; and skin rash

General Dosing Information
When choosing a sunscreen agent, some of the factors that should be taken into consideration are: type of activity, age, site of application, skin condition, and skin type. ^{33}

Table 2. Some factors to consider in selecting a sunscreen agent

Basic Factors	Determining Factors	Appropriate Sunscreen Agent
Type of activity ^{33}	High altitude activities such as mountain climbing and snow-skiing	Use SPF 15 or higher; UVA & UVB coverage
	Sweat-generating activities such as outdoor jobs (e.g., gardening, construction work), outdoor sports (e.g., tennis), or exercise, or prolonged sunbathing, watersports such as swimming, waterskiing, or windsurfing	Use SPF 15 or higher; water-resistant ³ or waterproof ⁴
	Reflective surfaces (e.g., concrete, sand, snow, water)	(Avoid such surfaces.) Use SPF 15 or higher; UVA & UVB coverage
Age ^{33}	Less than 6 months of age	Do not use sunscreen agents; keep out of sun
	6 months of age and older	Use SPF 15 or higher
		For children, use lotion sunscreen products; avoid alcohol-based products ^{32}
Site of application ^{33}	Ear, nose	Use physical sunscreen agent
	Lips	Use gel-based
Skin condition ^{33}	Dry	Use cream or lotion
	Oily	Use alcohol or gel-based
	Eczematous or inflamed	Avoid alcohol-based ^{32} ^{33}
Skin type ¹ (complexion) ^{01} ^{03} ^{06} ^{33} ^{48}		Appropriate Sunscreen Agent
Very fair—Always burns easily; rarely tans		SPF 20 to 30 ²
Fair—Always burns easily; tans minimally		SPF 12 to 20 ²
Light—Burns moderately; tans gradually (light brown)		SPF 8 to 12 ²
Medium—Burns minimally; always tans well (moderate brown)		SPF 4 to 8 ²
Dark—Rarely burns; tans profusely (dark brown)		SPF 2 to 4 ²

¹ Skin types are based on response to initial summer sun exposure for 30 minutes or longer ^{01}.
² Proposed FDA recommendations ^{48}.
³ Water-resistant sunscreen's photoprotective effect remains for up to 40 minutes of active immersion.
⁴ Waterproof (FDA has proposed name change to `very water-resistant' ^{48})—sunscreen's photoprotective effect remains after 80 minutes of active immersion.

Before every exposure to the sun, an appropriate sunscreen agent that protects against ultraviolet radiation should be used. ^{02} ^{11} ^{33} ^{54}

Sunscreen agents should be applied uniformly and generously to all exposed skin surfaces (including lips, using lip sunscreen or lip balm) prior to sun exposure. ^{43} ^{46} Sunscreen agents containing aminobenzoic acid and derivatives should be applied 1 to 2 hours before exposure to sun, while ^{33} all other sunscreen products should be applied 30 minutes prior to sun exposure. ^{01} ^{13} Lip sunscreens should be applied 45 to 60 minutes before sun exposure. ^{56}

Sunscreen agents should be reapplied liberally ^{08} ^{33} ^{43} ^{46} ^{54} after swimming or profuse sweating ^{43} ^{46} ^{54}. Because most sunscreens agents are easily removed from the skin, reapplication every 1 to 2 hours usually is required for adequate protection. ^{43} ^{46} Lip sunscreens should be reapplied liberally at least once every hour and also before and after swimming, after eating and drinking, and during other activities that remove it from the lips. ^{56}

In addition to using sunscreen agents, sun exposure should be minimized during the hours of 10 a.m. to 2 p.m. (11 a.m. to 3 p.m. daylight savings time) when the sun is strongest. Extra precautions should be utilized on cloudy or overcast days and around reflective surfaces such as concrete, sand, snow, or water since these surfaces can reflect up to 85% of the sun's damaging rays. ^{06} ^{33} ^{47} Sunlamps and tanning parlors should be avoided. ^{47} Because ultraviolet radiation can cause cataract formation, ultraviolet (UV)-opaque sunglasses should be worn. ^{47}

Topical Dosage Forms

Strength(s) usually available

Note: See Topical Dosage Forms, Table 3.

U.S.—

Table 3. Topical Dosage Forms

Sunscreen agent ingredients				SPF	Substantivity ^*	UV Coverage (UVA/UVB)	Other content information as per product label ^‡	Directions for use ^§	Auxiliary labeling ^#
	Brand name ^{43} ^{46} ^{150} ^{152} ^{154}
		Dosage form
			[availability]
Aminobenzoic acid/Padimate O/Oxybenzone						UVA/UVB
	Presun ^{128}			15			¹⁰	^1,6,11	^a,b,c,d
		Lotion
			[Canada]
Aminobenzoic acid/Titanium dioxide						UVA/UVB
	Formula 405 Solar ^{88}			15
		Lotion
			[U.S.]
Avobenzone/Octocrylene/Octyl salicylate/Oxybenzone						UVA/UVB
	Photoplex Plus Sunscreen ^{109}			15				^1,6,11	^a,b,d
		Lotion
			[Canada]
Avobenzone/Octyl methoxycinnamate						UVA/UVB
	Vaseline Broad Spectrum Sunblock ^{142}			15	^WP			^1,5,6,11
		Lotion
			[Canada]
Avobenzone/Octyl methoxycinnamate/Octyl salicylate/Oxybenzone						UVA/UVB
	Presun Sunscreen ^{128}			30	^WP			^1,6,11	^b
	Presun Sunscreen for Kids ^{128}			30	^WP			^1,6,11	^b
			Cream
	Presun Clear ^{128}			30	^WP		¹⁰	^1,6,11	^b,c
		Gel
			[Canada]
Avobenzone/Octyl methoxycinnamate/Oxybenzone						UVA/UVB
	Shade UVA Guard ^{59}			15	^WR		²	^1,6,11	^b,d
		Lotion
			[U.S.]
	Can Screen 400 Sunscreen ^{131}			22	^WR			^1,6,11	^b
	Ombrelle Sunscreen
		Lotion ^{126}		15	^WP			^1,4,6,11	^b
		Spray ^{127}		15	^WP		¹⁰	^2,4,6,11	^b,c
			[Canada]
Dioxybenzone/Oxybenzone/Padimate O						UVA/UVB
	Solbar Plus ^{98}			15
		Cream
			[U.S.]
Homosalate						UVB
	Coppertone Moisturizing Suntan			2	^WP		¹	^1,6,11	^b
		Oil ^{83}
	Tropical Blend Dark Tanning
		Lotion ^{104}		2	^WP		^1,2	^1,6	^b
		Oil		2	^WP
	Tropical Blend Dry Oil ^{46}			2				²	^b
		Spray
			[U.S.]
	Coppertone Dark Tanning ^{150}			2
		Oil
			[Canada]
Homosalate/Menthyl anthranilate/Octyl methoxycinnamate						UVA/UVB
	Hawaiian Tropic Protective Tanning Dry ^{46}			6				^1,11	^b
		Oil
			[U.S.]
Homosalate/Menthyl anthranilate/Octyl methoxycinnamate/Octyl salicylate/Oxybenzone						UVA/UVB
	Hawaiian Tropic Just for Kids ^{46}			30				^1,6,11	^b,d
	Hawaiian Tropic Sunblock ^{46}			30+
		Lotion
			[U.S.]
	Blistex Ultraprotection ^{138}			30	^WP			^3,8,11	^b
		Lip Balm
			[U.S./Canada]
Homosalate/Octocrylene/ Octyl methoxycinnamate/Oxybenzone						UVA/UVB
	Coppertone Waterproof Sunblock ^{150}			30	^WP
		Lotion
			[Canada]
Homosalate/Octyl methoxycinnamate/Octyl salicylate/Oxybenzone						UVA/UVB
	Coppertone All Day Protection ^{154}			30	^WP		²	^1,6,11	^b
	Coppertone Kids Sunblock ^{46}			15	^WP-6
	Neutrogena No Stick Sunscreen ^{114}			30	^WP		¹¹	^1,11	^b
	Shade Sunblock ^{96}			30	^WP		²	^1,6,11	^b
		Lotion
	Shade Sunblock ^{95}			30	^WP		⁵	^1,6,11	^b
		Stick
			[U.S.]
	Waterbabies Sunblock ^{150}			30	^WP		²	^1,6,11	^b
		Lotion
			[U.S./Canada]
Homosalate/Octyl methoxycinnamate/Oxybenzone						UVA/UVB
	Shade Oil-Free ^{88}			30	^WP		⁶	^1,6,11	^b,c
		Gel
			[U.S.]
Homosalate/Oxybenzone						UVA/UVB
	Tropical Blend Dry Oil ^{146}			4			⁵	²	^b
		Spray
			[U.S.]
Lisadimate/Oxybenzone/ Padimate O						UVA/UVB
	Total Eclipse Oily and Acne Prone Skin Sunscreen ^{46}			15			¹⁰		^b,c
		Lotion
			[U.S.]
Lisadimate/Padimate O						UVB
	Eclipse Original Sunscreen			10
		Lotion
			[U.S.]
Menthyl anthranilate						UVA/UVB
	Maxafil ^{43}			6-8
		Cream
			[U.S.]
Menthyl anthranilate/Octocrylene/Octyl methoxycinnamate						UVA/UVB
	Neutrogena Sunblock ^{120}			30	^WP-6			^1,6,11	^b
		Cream
			[U.S.]
Menthyl anthranilate/Octocrylene/Octyl methoxycinnamate/Oxybenzone						UVA/UVB
	Hawaiian Tropic Baby Faces ^{46}			20	^WP
	Hawaiian Tropic Plus ^{46}			15	^WP
		Gel
			[U.S.]
Menthyl anthranilate/Octyl methoxycinnamate						UVA/UVB
	Catrix Correction ^{77}			15			³	^9,13
	Neutrogena Sunblock ^{120}			8	^WP			^1,6,11	^b
		Cream
	Hawaiian Tropic Dark Tanning with Sunscreen ^{46}			4	^WP			^1,6,11	^b,d
		Lotion
			[U.S.]
Menthyl anthranilate/Octyl methoxycinnamate/Octyl salicylate						UVA/UVB
	Neutrogena Sunblock ^{120}			15	^WP-6		⁵	^1,6,11	^b
		Cream
			[U.S.]
Menthyl anthranilate/Octyl methoxycinnamate/Octyl salicylate/Oxybenzone						UVA/UVB
	Hawaiian Baby Faces Sunblock ^{46}			25	^WP
		Lotion
			[U.S.]
Menthyl anthranilate/Octyl methoxycinnamate/Oxybenzone ^{46}						UVA/UVB
	Hawaiian Tropic Plus			8	^WP-8
		Gel
	Hawaiian Tropic Plus			10	^WP-8
	Hawaiian Tropic Plus Sunblock			15
		Lip Balm
	Hawaiian Tropic Plus Sunblock			15	^WP-8		²	^1,6,11	^b,d
		Lotion
			[U.S.]
Menthyl anthranilate/Padimate O						UVA/UVB		^3,8,11	^b
	Blistex Medicated Lip Conditioner with Sunscreen ^{141}
		Lip Balm
			[Canada]
Menthyl anthranilate/Titanium dioxide						UVA/UVB
	A-Fil ^{91}			³				^1,7	^a
		Cream
			[U.S.]
Octocrylene/Octyl methoxycinnamate						UVB
	Bain de Soleil Mega Tan ^{70}						^1,14	^1,6,10,11	^a,b
	Bain de Soleil SPF + Color ^{71}			8	^WP		¹⁴	^1,6,10,11	^a,b
		Lotion
			[U.S.]
	Bain de Soleil Mega Tan ^{133}			4			¹⁴	^1,6,10,11	^a,b
		Lotion
			[Canada]
Octocrylene/Octyl methoxycinnamate/Octyl salicylate/Oxybenzone						UVA/UVB
	Coppertone All Day Protection ^{154}			45	^WP		²	^1,6,11	^b
	Coppertone Kids Sunblock ^{46}			30	^WP-6		^1,6
	Shade Sunblock ^{97}			45	^WP		²	^1,6,11	^b
	TI Screen ^{46}			30
		Lotion
			[U.S.]
	Coppertone Waterbabies Sunblock			45	^WP		²	^1,6,11	^b
	Shade Waterproof Sunblock			45	^WP
		Lotion
			[U.S./Canada]
Octocrylene/Octyl methoxycinnamate/Octyl salicylate/Oxybenzone/Titanium dioxide						UVA/UVB
	Bullfrog Sport ^{143}			18	^WP		²	^11,12	^b
	Hawaiian Tropic Baby Faces Sunblock			50	^WP		²
	Hawaiian Tropic Just For Kids			45	^WP			^1,6,11	^b,d
	Hawaiian Tropic Sport Sunblock			30	^WP-8
	Hawaiian Tropic Sunblock			45+				^1,6,11	^b,d
		Lotion
			[U.S.]
Octocrylene/Octyl methoxycinnamate/Oxybenzone						UVA/UVB
	Solbar PF Ultra ^{98}			50	^WP			^1,6,11
		Cream
	Solbar PF Liquid ^{98}			30			⁶	^1,6,11	^b,c
		Gel
			[U.S.]
	Bullfrog Body ^{75}			18 & 36	^WP			^11,12	^b
	Bullfrog Extra Moisturizing			18	^WP		^11,12		^b
	Bullfrog For Kids ^{57}			18 & 36	^WP-6			^11,12	^b
	Bullfrog Original Concentrated ^{76}			18 & 36	^WP			^11,12	^b
	Hawaiian Tropic Sport Sunblock			15	^WP		⁴	^1,6,11	^b,d
		Lotion
			[U.S.]
	Bain de Soleil SPF+ Color ^{72} ^{73}			15 & 30	^WP		¹³	^1,6,10,11	^a,b
		Lotion
			[Canada]
Octocrylene/Octyl methoxycinnamate/Oxybenzone/Titanium dioxide						UVA/UVB
	Bain de Soleil All Day For Kids			30	^WP			^1,6,11	^b
		Lotion
			[U.S.]
	Bain de Soleil All Day Sunblock ^{65} ^{66}			15 & 30	^WP-6		^1,11		^b
	Bain de Soleil Long Lasting For Kids ^{134}			30	^WP			^1,6,11	^b
	Bain de Soleil Long Lasting Sunblock ^{134}			15 & 30	^WP		^1,6,11		^b
		Lotion
			[Canada]
Octocrylene/Octyl methoxycinnamate/Titanium dioxide						UVA/UVB
	Bain de Soleil All Day Sunfilter ^{63} ^{64}			4 & 8	^WP-6			^1,11	^b
		Lotion
			[U.S.]
	Bain de Soleil Long Lasting Sport Sunblock ^{137}			15	^WP			^1,6,11	^b
	Bain de Soleil Long Lasting Sunfilter ^{74} ^{94}			4 & 8	^WP			^1,6,11	^b
		Lotion
			[Canada]
Octyl methoxycinnamate						UVB
	Coppertone Tan Magnifier ^{102}			4			²	^1,6,11	^b
	Formula 405 Solar			8
	Neutrogena Deep Glow ^{122}			8			^2,14	^10,11,17	^a,b
	Neutrogena Light Glow ^{122}			8			^2,14	^10,11,17	^a,b,d
	Q.T. Quick Tanning			2			^2,14	^1,6,10,11	^a,b
		Lotion
			[U.S.]
	Solbar Liquid
		Gel
			[Canada]
Octyl methoxycinnamate/Octyl salicylate						UVB
	Bain de Soleil Tropical Deluxe ^{69}			4	^WP		¹	^1,6,11	^b
	Hawaiian Tropic Land Sport			20
	Vaseline Intensive Care Moisturizing Sunscreen			4			²
		Lotion
	Bain de Soleil Sand Buster ^{68}			2	^WP		^1,5	^1,6,11	^b
		Oil
			[U.S.]
	Bain de Soleil Orange Gelee ^{62} ^{67}			4			¹²	^1,6,11	^a,b
		Gel
			[U.S./Canada]
Octyl methoxycinnamate/Octyl salicylate/Oxybenzone						UVA/UVB
	Banana Boat Faces Sensitive Skin Sunblock			15 & 23	^WP			^1,6,9
		Cream
	PreSun Active Clear			15 & 30	^WP		⁶	^1,6,11	^b,c
	Shade Sunblock Oil-Free			30	^WP		⁶		^b,c
	TI Screen			20+			⁶		^b,c
		Gel
	Waterbabies Little Licks			30	^WP		⁵	^3,11	^b
		Lip Balm
	Aquaray Sunscreen ^{61}			20	^WR			^1,6,11	^b
	Banana Boat Active Kids Sunblock			30+	^WP-8			^1,6
	Banana Boat Baby Sunblock			29	^WP-8			^1,6
	Banana Boat Sport Sunblock			15&30+	^WP-8			^1,6
	Dermsol ^{105}			30	^WP		²	^1,6,11	^b
	Durascreen			15	^WP-8		²	^1,6,11	^b
	Nivea Sun			15	^WP				^b
	PreSun For Kids			29	^WP
	PreSun Moisturizing Sunscreen with Keri			25	^WP
	PreSun Sensitive Skin			15 & 29	^WP
	TI Screen			20
		Lotion
	PreSun Spray Mist			23	^WP		⁶		^b,c
	Vaseline Intensive Care Moisturizing Sunblock ^{135}			25	^WP-8		²	^1,6,11	^b,d
		Spray
	Neutrogena Sunblock ^{120}			25	^WP		⁵	^11,14	^b
		Stick
			[U.S.]
	Presun Sunscreen ^{128}			29	^WP			^1,6,11	^b
	Presun Sunscreen for Kids ^{128}			29	^WP			^1,6,11	^b
	Solbar Shield			20
		Cream
			[Canada]
	Coppertone Sport ^{154}			30
	Vaseline Kids Sunblock ^{142}			25	^WP			^1,5,6,11
	Vaseline Sunblock ^{142}			25	^WP			^1,5,6,11
		Lotion
			[Canada]
Octyl methoxycinnamate/Octyl salicylate/Oxybenzone/Padimate O						UVA/UVB
	Presun Spray Mist for Kids			23	^WP		⁶
		Spray
			[U.S.]
	Vaseline Sunblock ^{142}			35	^WP			^1,5,6,11
		Lotion
			[Canada]
Octyl methoxycinnamate/Octyl salicylate/Oxybenzone/Padimate O/Titanium dioxide						UVA/UVB
	Vaseline Intensive Care Blockout Moisturizing ^{107}			40+	^WP			^1,6,11	^b,d
		Lotion
			[U.S.]
Octyl methoxycinnamate/Octyl salicylate/Oxybenzone/Phenylbenzimidazole/Titanium dioxide						UVA/UVB
	DuraScreen			30	^WR			^1,6,11	^b,d
		Lotion
			[U.S.]
Octyl methoxycinnamate/Octyl salicylate/Oxybenzone/Titanium dioxide						UVA/UVB
	Sundown Sunblock ^{115} ^{116}			15 & 30	^WP
	Vaseline Intensive Care Baby Moisturizing Sunblock			30+	^WP		²	^1,6,11	^b,d
	Vaseline Intensive Care Blockout Moisturizing ^{124}			30+	^WP
		Lotion
			[U.S.]
	Sundown Broad Spectrum Sunblock			15, 25, & 30
		Cream
	Vaseline Intensive Care Baby Sunblock ^{142}			25	^WP			^1,5,6,11
		Lotion
			[Canada]
	Johnson's Baby Sunblock ^{99}			15	^WP		¹
	Johnson's Baby Sunblock Extra Protection ^{99}			30+	^WP			^1,5,6,11	^b,d
		Lotion
			[U.S./Canada]
Octyl methoxycinnamate/Octyl salicylate/Phenylbenzimidazole/Titanium dioxide						UVA/UVB
	Eucerin Dry Skin Care Daily Facial ^{110}			20	^1,9,11	^b
		Lotion
			[U.S.]
Octyl methoxycinnamate/Octyl salicylate/Titanium dioxide						UVA/UVB
	Sundown Sunscreen			8	^WP
		Lotion
			[U.S.]
Octyl methoxycinnamate/Oxybenzone						UVA/UVB
	Aquaderm Sunscreen Moisturizer ^{58}			15				^1,9,11	^b
	DML Facial Moisturizer ^{86}			15	^1,9	^b
	Solbar PF ^{89}			15
	Vaseline Extra Defense for Hand and Body ^{108}			15			²
	Vaseline Extra Defense for Hand and Body ^{108}			15			²
	Vaseline Ultraviolet Daily Defense for Hand and Body ^{106}			4			²	^1,6	^b
		Cream
			[U.S.]
	Solbar PF Liquid ^{98}			15			⁶	^1,6,11	^b,c,d
		Gel
			[U.S.]
	Catrix Lip Saver ^{78}			15			^4,5	^3,15
	Neutrogena Lip Moisturizer ^{119}			15
	Vaseline Intensive Care Lip Therapy			8
		Lip Balm
	Coppertone All Day Protection			8 & 15	^WP			^1,6,11	^b
	Coppertone Moisturizing Sunscreen			6 & 8	^WP
	Coppertone Moisturizing Suntan ^{123}			4	^WP		²	^1,6,11	^b
	Coppertone Sport Ultra Sweatproof ^{84} ^{85}			8 & 15	^WP-8		²	^1,11	^b
	Curel Everyday Sun Protection			8				^1,6,11
	Hawaiian Tropic Self-tanning Sunblock			15			^2,14	^10,11	^a,b,d
	Neutrogena Moisture Untinted & with Sheer Tint ^{121}			15			⁷	^4,9,11	^b
	Softsense Skin Essential Everyday UV Protectant			8
	TI Screen			8 & 15+
	Tropical Blend Dark Tanning			4	^WP		^1,2	^1,6	^b
	Vaseline Intensive Care Active Sport ^{147}			8 & 15	^WP-8			^1,6,11	^b,d
	Vaseline Intensive Care Moisturizing Sunblock ^{148}			15	^WP-8		²	^1,6,11	^b,d
		Lotion
	Bullfrog Sunblock ^{112}			18	^WP-6			^11,14	^b
		Stick
			[U.S.]
	Vaseline Lip Therapy ^{142}			15	^WP			^3,8,11
		Lip Balm
	TI-UVA-B Sunscreen ^{132}			22	^WR			^1,11,16	^b
	Vaseline Kids Sunblock ^{142}			15	^WP			^1,5,6,11
	Vaseline Sport Sunblock ^{142}			15	^WP			^1,5,6,11
	Vaseline Sports Sunscreen ^{142}			8	^WP			^1,5,6,11
	Vaseline Sunblock ^{142}			15	^WP			^1,5,6,11
	Vaseline Sunscreen ^{142}			8	^WP			^1,5,6,11
		Lotion
	Sundown Sunscreen			15
		Stick
			[Canada]
	Coppertone Lipkote			15	^WP		⁵	^3,8,11
		Lip Balm
			[U.S./Canada]
	Waterbabies Sunblock			15			²
		Lotion
			[U.S./Canada]
Octyl methoxycinnamate/Oxybenzone/Padimate O						UVA/UVB
	Banana Boat Sunblock			15	^WP			^1,6
		Lotion
			[U.S.]
Octyl methoxycinnamate/Oxybenzone/Padimate O/Titanium dioxide						UVA/UVB
	Sundown			20
		Stick
			[Canada]
Octyl methoxycinnamate/Oxybenzone/Titanium dioxide						UVA/UVB
	Hawaiian Tropic Water Sport			20
		Lotion
			[U.S.]
Octyl methoxycinnamate/Padimate O						UVB
	Banana Boat Dark Tanning			4			¹	^1,6
	Banana Boat Protective Tanning			8				^1,6
	Hawaiian Tropic Dark Tanning			4	^WP
		Oil
			[U.S.]
Octyl methoxycinnamate/Phenylbenzimidazole						UVB
	Neutrogena Intensified Day Moisture ^{118}			15			²	^9,11	^b
	Noxzema Moisturizer ^{90}			15			²	^1,6,9,11	^b
	Oil of Olay Daily UV Protectant ^{93}			15			²	^1,11	^b
		Cream
	Oil of Olay Daily UV Protectant Beauty Fluid ^{92}			15			²	^1,11	^b
	Oil of Olay Moisture Replenishment ^{92}			15			²	^1,11	^b
		Lotion
			[U.S.]
	Pond's Daily Replenishing Moisturizer ^{142}			15			²	^1,11	^b
		Lotion
			[Canada]
Octyl salicylate						UVB
	PreSun Spray Mist			15	^WP
		Spray
			[U.S.]
Octyl salicylate/Padimate O						UVB
	Total Eclipse Moisturizing Skin			15
		Lotion
			[U.S.]
Oxybenzone/Padimate O						UVA/UVB
	Blistex Daily Conditioning Treatment for Lips ^{145}			15	^WR†		¹	^3,8,11	^b
	Blistex Regular ^{144}			10	^WR†		^1,2	^3,8,11	^b
	Chap-et Sun Ban Lip Conditioner			15				³
	Chap Stick Sunblock Petroleum Jelly Plus ^{80}			15
	PreSun Lip Protector			15
	Stay Moist Moisturizing Lip Conditioner ^{125}			15+				^3,9,11	^b
		Lip Balm
	Banana Boat Sunscreen			8	^WP
	Formula 405 Solar			15				^3,8,11
	Hawaiian Tropic Protective Tanning			6
	PreSun Moisturizing			46
	PreSun Moisturizing Sunscreen with Keri			8 & 15	^WP
	Ray Block ^{60}			15			⁶	^1,11	^b,c
	Solex A15 Clear			15					^b
		Lotion
	Tropical Blend Dark Tanning			4	^WP			^1,6	^b
		Oil
			[U.S.]
	Eclipse Lip & Face Protectant			15
		Stick
			[U.S.]
	Presun Sunscreen			39	^WP			^1,6,11	^b,d
		Cream
	Blistex Medicated Lip Conditioner ^{140}			15				^3,8,11
	Blistex Sunblock ^{139}			15				³
		Lip Balm
	PreSun Creamy			15	^WP			^1,6,11	^b,d
	Sundown Sunscreen			8
		Lotion
	Tropical Blend Waterproof			4	^WP
		Oil
			[Canada]
	Chap Stick Sunblock ^{79}			15			^1,2	^3,11	^b
		Lip Balm
			[U.S./Canada]
Oxybenzone/Roxadimate						QUVA/UVB
	Solbar Plus			15
		Cream
	Solbar
		Lotion
			[Canada]
Padimate O						UVB
	Herpecin-L Cold Sore ^{111}			15			⁴	^3,8,11
	Mentholatum			14.7			¹
		Lip Balm
	Banana Boat Dark Tanning			4	^WP
		Lotion
	Banana Boat Dark Tanning			2			¹	^1,6
		Oil
			[U.S.]
	Chap Stick ^{81}			4			^1,2	³
		Lip Balm
			[U.S.]
Phenylbenzimidazole						UVB
	Coppertone Tan Magnifier ^{101}			4			⁹	^1,6,11	^b
	Hawaiian Tropic Dark Tanning			2				^1,11	^b
		Gel
			[U.S.]
	Oil of Olay Moisture Replenishment			15			²	^1,11	^b
		Lotion
			[U.S.]
	Pond's Daily Replenishing Moisturizer			15			²	^1,11	^b
		Lotion
			[Canada]
Phenylbenzimidazole/Sulisobenzone						UVA/UVB
	Hawaiian Tropic Protective Tanning Dry			6
		Gel
			[U.S.]
Titanium dioxide						UVA/UVB
	Neutrogena Chemical-Free Sunblocker ^{113}			17	^WR		⁷	^1,6,11	^b
	TI Screen Baby Natural			16	^WP
	Vaseline Intensive Care Baby Moisturizing Sunblock			15	^WP			^1,6,11	^b,d
		Lotion
			[U.S.]
Titanium dioxide/Zinc oxide						UVA/UVB
	Sundown Sport Sunblock ^{117}			15	^WP			^1,5,6,11	^b
		Lotion
			[U.S.]
	Vaseline Baby Sunblock ^{142}			15	^WP			^1,5,6,11
		Lotion
			[Canada]
	Johnson's No More Tears Baby Sunblock ^{100}			15	^WP		¹	^1,5,6,11	^b,d
		Lotion
			[U.S./Canada]
Trolamine salicylate						UVB
	Coppertone Tan Magnifier ^{103}			2 & 4			²	^1,6	^b
		Oil
			[U.S.]

^* For appropriate substantivity information, refer to the designated symbols as follows

• WR—Water-resistant (FDA defines as a sunscreen that maintains its photoprotective effect for up to 40 minutes of active immersion)

• WR†—Water-resistant - 80 minutes

• WP—Waterproof - (FDA defines as a sunscreen that maintains its photoprotective effect after 80 minutes of active immersion; FDA has proposed name change to very water-resistant)

• WP-6—Waterproof - 6 hours

• WP-8—Waterproof - 8 hours

^§ For appropriate directions for use, refer to the designated numbers as follows

   #149; Apply liberally and evenly to all exposed areas before exposure to the sun.
   #149; Apply liberally and evenly, spraying 6 to 8 inches above the skin. For face, spray into hands and finger-apply.
   #149; Apply liberally and evenly to lips before and during exposure to the sun.
   #149; Apply 15 to 30 minutes before sun exposure.
   #149; Apply 30 minutes before sun exposure.
   #149; Reapply after swimming or excessive sweating or towel drying.
   #149; Reapply every 2 hours or after swimming or excessive sweating.
   #149; Reapply after eating or drinking.
   #149; Compatible for use under makeup.
   #149; When using on the face, smooth on a thin, even coat and blend in quickly until the product is completely absorbed. Use sparingly around hairline and eyebrows. This product contains a self-tanning ingredient; wash and wipe palms thoroughly, even between fingers, after each application to avoid ``tanning'' on inside of hands.
   #149; Discontinue use if signs of irritation or rash appear.
   #149; Smooth evenly and generously onto dry skin. Wait 5 minutes. Rub it again. Reapply only after toweling off.
   #149; Apply morning and evening for 1 week before beginning chemical treatment therapy. If skin is already irritated by chemical treatment, discontinue sunscreen use and apply only after irritation subsides. Apply a few minutes after topical applications of the chemical treatment. Reapply throughout the day, particularly morning and evening, to cleansed skin.
   #149; Rub on sensitive areas such as the face, lips, nose, ears, and shoulders. Apply liberally. Reapply as needed.
   #149; May use on nose and around eyes in addition to the lips.
   #149; Reapply after 40 minutes in the water or excessive sweating.
   #149; Wait 1 hour before bathing or swimming.

^‡ For other content refer to the designated numbers as follows:

   #149; Lanolin
   #149; Methyl- and propylparabens
   #149; Butyl-, methyl-, and propylparabens
   #149; Allantoin
   #149; Propylparaben
   #149; SD alcohol 40
   #149; Ethyl-, methyl-, and propylparabens
   #149; Butyl-, isobutyl-, and methylparabens
   #149; Methylparaben
   #149; Alcohol
   #149; Butyl-, ethyl-, isobutyl-, isopropyl-, and methylparabens
   #149; Butyl- and propylparabens
   #149; Hydroxyacetone (self-tanning ingredient)
   #149; Dihydroxyacetone (self-tanning ingredient)
   #149; Butyl- and methylparabens

^# For auxiliary labeling information, refer to the designated letters as follows

   • May stain clothing.
   • Avoid contact with eyes.
   • Flammable, do not use near heat or flame.
   • Shake well before using.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Revised: 04/02/1996

References

Buescher LS. Sunscreens and photoprotection. Otolaryngol Clin North Am 1993 Feb; 26(1): 13-22.

Stiller MJ, Davis IC, Shupack JL. A concise guide to topical sunscreens: state of the art. Int J Dermatol 1992 Aug; 31(8): 540-3.

Sterling GB. Sunscreens: a review. Cutis 1992 Sep; 50(3): 221-4.

Marmelzat J, Rapaport MJ. Photodermatitis with PABA. Contact Dermatitis 1980; 6: 230-1.

Rapaport MJ. Choosing a broad-spectrum sunscreen with UVA protection. Dermatol Nurs 1991 Apr; 3(2): 83-6, 88-9, 102.

Zanowiak P. Protecting the skin from solar radiation. US Pharm 1993; 20(suppl): 14-29.

Roelandts R, Vanhee J, Bonamie A, et al. A survey of ultraviolet absorbers in commercially available sun products. Int J Dermatol 1983 May; 22: 247-55.

Stenberg C, Larko O. Sunscreen application and its importance for the sun protection factor. Arch Dermatol 1985 Nov; 121: 1400-2.

Sams, WM Jr. Assessment of the photosensitive patient. Dermatol Nurs 1992; 4(1): 30-4.

Anonymous. Sunscreens and insect repellents. Can Pharm J 1993; 126: 250-1, 255.

Anonymous. Sunscreen protection controversy heats up. JAMA 1991; 265(24): 3218-20.

Anonymous. Sunscreen users: don't worry about vitamin `D'-ficiency. Sun and Skin News 1995; 12(1): 3.

Wiss K. Lasers, tissue expansion, and sun protection in pediatric dermatology. Cutis 1990 May; 45(5): 331-4.

Truhan AP. Sun protection in childhood. Clin Pediatr (Phila) 1991 Dec; 30(12): 676-81.

Thompson SC, Jolley D, Marks R. Reduction of solar keratoses by regular sunscreen use. N Engl J Med 1993 Oct 14; 329(16): 1147-51.

Rooney JF, Bryson Y, Mannix ML, et al. Prevention of ultraviolet-light-induced herpes labialis by sunscreen. Lancet 1991 Dec 7; 338(8780): 1419-22.

Callen JP, Roth DE, McGrath C, et al. Safety and efficacy of a broad-spectrum sunscreen in patients with discoid or subacute cutaneous lupus erythematosus. Cutis 1991 Feb; 47(2): 130-2, 135-6.

Proby CM, Baker CS, Morton O, et al. New broad-spectrum sunscreen for polymorphic light eruption [letter; comment]. Lancet 1993 May 22; 341(8856): 1347-8.

Foley P, Nixon R, Marks R, et al. The frequency of reactions to sunscreens: results of a longitudinal population-based study on the regular use of sunscreens in Australia. Br J Dermatol 1993 May; 128(5): 512-8.

Hogan D. Potential dangers of alcohol-based sunscreens [letter]. JAMA 1992 Oct 28; 268(16): 2169.

DeLeo VA, Suarez SM, Maso MJ. Photoallergic contact dermatitis. Results of photopatch testing. Arch Dermatol 1992 Nov; 128(11): 1513-8.

Hölzle E, Neumann N, Hausen B, et al. Photopatch testing: the 5-year experience of the German, Austrian, and Swiss Photopatch Test Group. J Am Acad Dermatol 1991 Jul; 25(1 Pt 1): 59-68.

Green C, Catterall M, Hawk JL. Chronic actinic dermatitis and sunscreen allergy. Clin Exp Dermatol 1991 Jan; 16(1): 70-1.

Peluso AM, Bardazzi F, Tosti A. Photocontact dermatitis due to Eusolex 4360. Contact Dermatitis 1991 Jul; 25(1): 65-6.

Green C, Norris PG, Hawk JL. Photoallergic contact dermatitis from oxybenzone aggravating polymorphic light eruption. Contact Dermatitis 1991 Jan; 24(1): 62-3.

Torres V, Correia T. Contact and photocontact allergy to oxybenzone and mexenone. Contact Dermatitis 1991 Aug; 25(2): 126-7.

Lenique P, Machet L, Vaillant L, et al. Contact and photocontact allergy to oxybenzone. Contact Dermatitis 1992 Mar; 26(3): 177-81.

Bilsland D, Ferguson J. Contact allergy to sunscreen chemicals in photosensitivity dermatitis/actinic reticuloid syndrome (PD/AR) and polymorphic light eruption (PLE). Contact Dermatitis 1993 Aug; 29(2): 70-3.

Fisher AA. Sunscreen dermatitis: Part IV--The salicylates, the anthranilates, and physical agents. Cutis 1992 Dec; 50(6): 397-8.

Fisher AA. Sunscreen dermatitis: Part III--The benzophenones [news]. Cutis 1992 Nov; 50(5): 331-2.

Fisher AA. Sunscreen dermatitis: Part II--The cinnamates [news]. Cutis 1992 Oct; 50(4): 253-4.

Fisher AA. Sunscreen dermatitis: para-aminobenzoic acid and its derivatives. Cutis 1992 Sep; 50(3): 190-2.

Pellatt SG. Sunscreens. In: Carruthers-Czyzewski P, editor. Self-medication: reference for health professionals, Vol 1. 4th ed. Toronto, Canada: CK Productions, 1992: 49-61.

Pathak MA. Sunscreens: topical and systemic approaches for protection of human skin against harmful effects of solar radiation. J Am Acad Dermatol 1982; 7(3): 285-312.

Dromgoole SH, Maibach HI. Sunscreening agent intolerance: contact and photocontact sensitization and contact urticaria. J Am Acad Dermatol 1990 Jun; 22(6 Pt 1): 1068-78.

Horio T, Higuchi T. Photocontact dermatitis from p-aminobenzoic acid. Dermatologica 1978; 156: 124-8.

Rietschel RL, Lewis CW. Contact dermatitis to homomenthyl salicylate. Arch Dermatol 1978; 114: 442-3.

Kaidbey KH, Kligman AM. Phototoxicity to a sunscreen ingredient. Arch Dermatol 1978; 114: 547-9.

Mathias CGT, Maibach HI, Epstein J. Allergic contact photodermatitis to para-aminobenzoic acid. Arch Dermatol 1978; 114: 1665-6.

Thompson G, Maibach H, Epstein J. Allergic contact dermatitis from sunscreen preparations complicating photodermatitis. Arch Dermatol 1977; 113: 1252-3.

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Ramsey DL, Cohen HJ, Baer RL. Allergic reactions to benzophenone. Arch Dermatol 1972; 105: 906-8.

McEvoy GK, editor. AHFS Drug information 95. Bethesda, MD: American Society of Hospital Pharmacists, 1995: 2498-501.

Goodman TF. Photodermatitis from a sunscreening agent. Arch Dermatol 1970; 102: 563.

Stern RS, Weinstein MC, Baker SS. Risk reduction for non-melanoma skin cancer with childhood sunscreen use. Arch Dermatol 1986; 122: 537-45.

Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1994: 562-562j.

Hurwitz S. The sun and sunscreen protection: recommendations for children. J Dermatol Surg Oncol 1988; 14: 657-60.

Fed Regist. Sunscreen drug products for over-the-counter human use. Part III, 28297, May 12, 1993.

Fine RM. Sunscreens and cutaneous vitamin D synthesis. Int J Dermatol 1988; 27: 300-1.

Green HA, Drake L. Aging, sun damage and sunscreens. Clin Plast Surg 1993 Jan; 20: 1-8.

Gilchrest BA. Sunscreens—a public health opportunity [letter]. N Engl J Med 1993 Oct; 329(16): 1193-4.

Lowe NJ, Shaath NA, editors. Sunscreens: development, evaluation, and regulatory aspects. New York: Marcel Dekker, 1990: 313-40, 359-78, 459-68, 550.

Fleeger CA, editor. USAN 1994. USAN and the USP dictionary of drug names, Rockville, MD: The United States Pharmacopeial Convention, Inc., 1993: 42, 63, 152, 213, 220, 326, 381, 474, 488, 492, 587, 631, 672, 720.

Anonymous. Excessive sun exposure; some people at risk. World Health Forum 1993; 14(4): 435-7.

Harvey SC. Topical drugs. In: Gennaro AR, editor. Remington's pharmaceutical sciences. Easton: Mack Publishing, 1990: 773.

Anonymous. Proper use of products for damaged lips. Pharmacist 1994 Apr: 43-4, 46.

Octocrylene, octyl methoxycinnamate, and oxybenzone box label (Bullfrog For Kids, Chattem—US), Rec 1/94.

Octyl methoxycinnamate and oxybenzone box label (Aquaderm Sunscreen Moisturizer, Baker Cummins Dermatologicals—US), Rev 12/92, Rec 12/93.

Avobenzone, octyl methoxycinnamate, and oxybenzone box label (Shade UVA Guard, Schering-Plough HealthCare Products—US), Rec 8/93.

Oxybenzone and padimate O package insert (Ray Block Sunscreen Lotion, Del Ray Laboratory—US), Rec 12/93.

Octyl methoxycinnamate, octyl salicylate, and oxybenzone package insert (Aquaray Sunscreen, Herald Pharmacal—US), Rec 4/94.

Octyl methoxycinnamate and octyl salicylate box label (Bain de Soleil Orange Gelee, Herdt & Charton—Canada), Rec 6/94.

Octocrylene, octyl methoxycinnamate, and titanium dioxide package insert (Bain de Soleil All Day Sunfilter SPF 4, Proctor & Gamble—US), Rec 5/94.

Octocrylene, octyl methoxycinnamate, and titanium dioxide package insert (Bain de Soleil All Day Sunfilter SPF 8, Proctor & Gamble—US), Rec 5/94.

Octocrylene, octyl methoxycinnamate, oxybenzone, and titanium dioxide package insert (Bain de Soleil All Day Sunblock SPF 15, Herdt & Charton—Canada), Rec 6/94.

Octocrylene, octyl methoxycinnamate, oxybenzone, and titanium dioxide package insert (Bain de Soleil All Day Sunblock SPF 30, Herdt & Charton—Canada), Rec 6/94.

Octyl methoxycinnamate and octyl salicylate box label (Bain de Soleil Orange Gelee, Proctor & Gamble—US), Rec 5/94.

Octyl methoxycinnamate and octyl salicylate package insert (Bain de Soleil Sand Buster, Proctor & Gamble—US), Rec 5/94.

Octyl methoxycinnamate and octyl salicylate package insert (Bain de Soleil Tropical Deluxe, Proctor & Gamble—US), Rec 5/94.

Octocrylene and octyl methoxycinnamate package insert (Bain de Soleil Mega Tan, Proctor & Gamble—US), Rec 5/94.

Octocrylene and octyl methoxycinnamate package insert (Bain de Soleil SPF+ Color, Proctor & Gamble—US), Rec 5/94.

Octocrylene, octyl methoxycinnamate, and oxybenzone package insert (Bain de Soleil SPF+ Color SPF 15, Herdt & Charton—Canada), Rec 6/94.

Octocrylene, octyl methoxycinnamate, and oxybenzone package insert (Bain de Soleil SPF+ Color SPF 30, Herdt & Charton—Canada), Rec 6/94.

Octocrylene, octyl methoxycinnamate, and titanium dioxide box label (Bain de Soleil All Day Sunfilter, Herdt & Charton—Canada), Rec 6/94.

Octocrylene, octyl methoxycinnamate, and oxybenzone box label (Bullfrog Body SPF 36, Chattem—US), Rec 1/94.

Octocrylene, octyl methoxycinnamate, and oxybenzone box label (Bullfrog Original Concentrated SPF 18, Chattem—US), Rec 1/94.

Menthyl anthranilate and octyl methoxycinnamate package insert (Catrix Correction, Donnell-Dermedex—US), Rec 12/93.

Octyl methoxycinnamate and oxybenzone package insert (Catrix Lip Saver, Donnell-Dermedex—US), Rec 12/93.

Oxybenzone and padimate O box label (Chap Stick Sunblock, Whitehall-Robins—US), Rec 5/94.

Oxybenzone and padimate O package insert (Chap Stick Sunblock Petroleum Jelly Plus, Whitehall-Robins—US), Rec 5/94.

Padimate O package insert (Chap Stick, Whitehall-Robins—US), Rec 5/94.

Correspondence (Playtex Products Inc—US), 10/94.

Homosalate bottle label (Coppertone Moisturizing Suntan SPF 2, Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate and oxybenzone bottle label (Coppertone Sport Ultra Sweatproof SPF 8, Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate and oxybenzone bottle label (Coppertone Sport Ultra Sweatproof SPF 15, Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate and oxybenzone package insert (DML Facial Moisturizer, Person & Covey—US), Rec 12/93.

Fed Regist 1994 Apr; Parts 352, 700, 740: 1-7.

Formula 405 Solar, Shade Oil-Free. In: Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 256, 504.

Octyl methoxycinnamate and oxybenzone package insert (Solbar PF Liquid, Person & Covey—US), Rec 12/93.

Octyl methoxycinnamate and phenylbenzimidazole box label (Noxzema Moisturizer, Procter & Gamble—US), Rec 5/94.

Menthyl anthranilate and titanium dioxide box label (A-Fil, GenDerm—US), Rec 4/94.

Octyl methoxycinnamate and phenylbenzimidazole box label (Oil of Olay Daily UV Protectant Beauty Fluid, Proctor & Gamble—US), Rec 5/94.

Octyl methoxycinnamate and phenylbenzimidazole box label (Oil of Olay Daily UV Protectant, Proctor & Gamble—US), Rec 5/94.

Octocrylene, octyl methoxycinnamate, and titanium dioxide box label (Bain de Soleil Long Lasting Sunfilter, Herdt & Charton—Canada), Rec 6/94.

Homosalate, octyl methoxycinnamate, octyl salicylate, and oxybenzone bottle label (Shade Sunblock SPF 30 [Stick], Schering-Plough—US), Rec 4/94.

Homosalate, octyl methoxycinnamate, octyl salicylate, and oxybenzone bottle label (Shade Sunblock SPF 30 [Lotion], Schering-Plough—US), Rec 4/94.

Octocrylene, octyl methoxycinnamate, octyl salicylate and oxybenzone box label (Shade Sunblock SPF 45 [Lotion], Schering-Plough—US), Rec 4/94.

Octocrylene, octyl methoxycinnamate, and oxybenzone package inserts (Solbar PF Ultra, Solbar PF Liquid, Person & Covey—US), Rec 12/93.

Octyl methoxycinnamate, octyl salicylate, oxybenzone, and titanium dioxide bottle labels (Johnson's Baby Sunblock, Johnson's Baby Sunblock Extra Protection, Johnson & Johnson—US), Rec 10/94.

Titanium dioxide and zinc oxide bottle label (Johnson's No More Tears Baby Sunblock, Johnson & Johnson—US), Rec 10/94.

Phenylbenzimidazole bottle label (Coppertone Tan Magnifier SPF 4 [Gel], Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate bottle label (Coppertone Tan Magnifier SPF 4 [Lotion], Schering-Plough—US), Rec 4/94.

Trolamine salicylate bottle labels (Coppertone Tan Magnifier Oil SPF 2 [Oil], SPF 4 [Oil], Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate and oxybenzone bottle label (Tropical Blend Dark Tanning, Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate, octyl salicylate, and oxybenzone box label (Dermsol, Parnell—US), Rec 5/94.

Octyl methoxycinnamate and oxybenzone product development fact sheet (Vaseline Ultraviolet Daily Defense for Hand and Body, Chesebrough-Pond—US), Rec 5/94.

Octyl methoxycinnamate, octyl salicylate, oxybenzone, padimate O, and titanium dioxide product development fact sheet (Vaseline Intensive Care Blockout Moisturizing, Chesebrough-Pond—US), Rec 5/94.

Octyl methoxycinnamate and oxybenzone product development fact sheet (Vaseline Extra Defense for Hand and Body, Chesebrough-Pond—US), Rec 5/94.

Avobenzone, octocrylene, octyl salicylate, and oxybenzone box label (Photoplex Plus Sunscreen, Allergan Herbert—Canada), Rec 6/94.

Octyl methoxycinnamate, octyl salicylate, phenylbenzimidazole, and titanium dioxide container label (Eucerin Dry Skin Care Daily Facial, Beiersdorf—US), Rec 10/94.

Padimate O box label (Herpecin-L Cold Sore, Campbell—US), Rec 4/94.

Octyl methoxycinnamate and oxybenzone box label (Bullfrog Sunblock, Chattem—US), Rec 1/94.

Titanium dioxide bottle label (Neutrogena Chemical-Free Sunblocker, Neutrogena—US), Rec 6/94.

Homosalate, octyl methoxycinnamate, octyl salicylate, and oxybenzone bottle label (Neutrogena No Stick Sunscreen, Neutrogena—US), Rec 6/94.

Octyl methoxycinnamate, octyl salicylate, oxybenzone, and titanium dioxide bottle label (Sundown Sunblock SPF 15, Johnson & Johnson—US), Rec 10/94.

Octyl methoxycinnamate, octyl salicylate, oxybenzone, and titanium dioxide bottle label (Sundown Sunblock SPF 30, Johnson & Johnson—US), Rec 10/94.

Titanium dioxide and zinc oxide bottle label (Sundown Sport Sunblock, Johnson & Johnson—US), Rec 10/94.

Octyl methoxycinnamate and phenylbenzimidazole box label (Neutrogena Intensified Day Moisture, Neutrogena—US), Rec 6/94.

Octyl methoxycinnamate and oxybenzone box label (Neutrogena Lip Moisturizer, Neutrogena—US), Rec 6/94.

Neutrogena products information (Neutrogena—US), Rec 6/94.

Octyl methoxycinnamate and oxybenzone box label (Neutrogena Moisture Untinted & with Sheer tint, Neutrogena—US), Rec 6/94.

Octyl methoxycinnamate bottle label (Neutrogena Light Glow, Neutrogena—US), Rec 6/94.

Octyl methoxycinnamate and oxybenzone box label (Coppertone Moisturizing Suntan SPF 4, Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate, octyl salicylate, oxybenzone, and titanium dioxide product development fact sheet (Vaseline Intensive Care Blockout Moisturizing, Chesebrough-Pond—US), Rec 5/94.

Oxybenzone and padimate O box label (Stay Moist Moisturing Lip Conditioner SPF 15, Stanback Co—US), Rec 6/94.

Avobenzone, octyl methoxycinnamate, and oxybenzone box label (Ombrelle Sunscreen [Lotion], Dermtek Pharmaceuticals—Canada), Rec 6/94.

Avobenzone, octyl methoxycinnamate, and oxybenzone box label (Ombrelle Sunscreen [Spray], Dermtek Pharmaceuticals—Canada), Rec 6/94.

Presun products. In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 1056.

Mentholatum (Mentholatum). In: Redbook 1993. Montvale, NJ: Medical Economics Data, 1993: 363.

OPEN

Avobenzone, octyl methoxycinnamate, and oxybenzone box label (Can Screen 400 Sunscreen, Tican Pharmaceuticals—Canada), Rec 6/94.

Octyl methoxycinnamate and oxybenzone bottle label (TI-UVA-B Sunscreen, Tican Pharmaceuticals—Canada), Rec 6/94.

Octocrylene and octyl methoxycinnamate box label (Bain de Soleil Mega Tan, Herdt & Charton—Canada), Rec 6/94.

Octocrylene, octyl methoxycinnamate, oxybenzone, and titanium dioxide bottle label (Bain de Soleil Long Lasting For Kids, Herdt & Charton—Canada), Rec 6/94.

Octyl methoxycinnamate, octyl salicylate, and oxybenzone bottle label (Vaseline Intensive Care Moisturizing Sunblock SPF 25, Chesebrough-Ponds—US), Rec 5/94.

OPEN

Octocrylene, octyl methoxycinnamate, and titanium dioxide box label (Bain de Soleil Long Lasting Sport Sunblock, Herdt & Charton—Canada), Rec 6/94.

Homosalate, menthyl anthranilate, octyl methoxycinnamate, octyl salicylate, and oxybenzone box label (Blistex Ultraprotection, Blistex—Canada), Rec 6/94.

Oxybenzone and padimate O box label (Blistex Sunblock, Blistex—Canada), Rec 6/94.

Oxybenzone and padimate O box label (Blistex Medicated Lip Conditioner, Blistex—Canada), Rec 6/94.

Menthyl anthranilate and padimate O box label (Blistex Medicated Lip Conditioner with Sunscreen, Blistex—Canada), Rec 6/94.

Correspondence (Chesebrough-Ponds—Canada), 7/94.

Octocrylene, octyl methoxycinnamate, octyl salicylate, oxybenzone, and titanium dioxide container label (Bullfrog Sport, Chattem—US), Rec 1/94.

Oxybenzone and padimate O box label (Blistex Regular, Blistex—US), Rec 4/94.

Oxybenzone and padimate O box label (Blistex Daily Conditioning Treatment for Lips, Blistex—US), Rec 4/94.

Homosalate and oxybenzone box label (Tropical Blend Dry Oil, Schering-Plough—US), Rec 4/94.

Octyl methoxycinnamate and oxybenzone bottle label (Vaseline Intensive Care Active Sport, Chesebrough-Ponds—US), Rec 5/94.

Octyl methoxycinnamate and oxybenzone bottle label (Vaseline Intensive Care Moisturizing Sunblock SPF 15, Chesebrough-Ponds—US), Rec 5/94.

OPEN

Carruthers-Czyzewski P, editor. CNP Compendium of nonprescription products. 1st ed. Ottawa: Canadian Pharmaceutical Association, 1994: 378-86.

Naylor MF, Boyd A, Smith DW, et al. High sun protection factor sunscreens in the suppression of actinic neoplasia. Arch Dermatol 1995; 131: 170-5.

Reviewers' consensus on Sunscreen Agents (Topical) monograph draft of 8/95.

Panel comment, 9/95.

Manufacturer's comment, 9/95.

Panel comment, 9/95.

Matsuoka LY, Wortsman JM, Hanifan N, et al. Chronic sunscreen use decreases circulating concentrations of 25-hydroxyvitamin D. Arch Dermatol 1988; 124: 1802-4.

Matsuoka LY, Ide L, McLaughlin JA, et al. Sunscreens suppress cutaneous vitamin D3 synthesis. J Clin Endocrinol Metab 1987; 64: 1165-8.

Marks R, Foley PA, Jolley D, et al. The effect of regular sunscreen use on vitamin D levels in an Australian population. Arch Dermatol 1995; 131: 415-21.

Fleeger CA, editor. USP dictionary of USAN and international drug names, 1996. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1995: 44, 66, 234, 344, 404, 501, 516, 520, 618, 665, 707, 758.

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