Professional Information

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}</

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