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SUN DEFENSE SPF 30

Dosage form: lotion
Ingredients: AVOBENZONE 25mg in 1mL, OCTINOXATE 75mg in 1mL, OXYBENZONE 6mg in 1mL, TITANIUM DIOXIDE 20mg in 1mL
Labeler: Kamins Dermatologics Inc.
NDC Code: 63550-851

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

SUN DEFENSE SPF30 CONSUMER LABELING

Active ingredients:

Avobenzone 2.5%

Octinoxate 7.5%

Oxybenzone 6%

Titanium dioxide 2%

Purpose: Sunscreen

Keep out of reach of children.

This oil and fragrance-free broad spectrum UVA/UVB sunscreen provides important protection against the sun’s harmful rays. Recommended for use on face and body, for everyday wear and outdoor activities. This cosmetically elegant formula is non-greasy, leaves a matte finish, and can be reapplied over makeup.

• fragrance-free • oil-free
• for face and body

Uses

■ Helps prevent sunburn.

■ Higher SPF gives more sunburn protection.

■ Provides high protection against sunburn.

Warnings

For external use only.

When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Other information

Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Store at room temperature 15-30°C (59-86°F).

Directions

■ Apply liberally and evenly to face and exposed areas 15-30 minutes before sun exposure.

■ Reapply every two hours or as needed.

■ Reapply after swimming, towel drying, washing or perspiring heavily.

■ Children under 6 months of age: ask a doctor.

Inactive ingredients: water, octyldodecyl neopentanoate, propylene glycol, acer saccharum, tocopheryl acetate, cetyl alcohol, stearic acid, DEA-cetyl phosphate, panthenol, dimethicone, xanthan gum, carbomer, sodium hydroxide, phenoxyethanol, chlorphenesin, BHT, iron oxides (CI 77491).

SUN DEFENSE SPF 30

120 mL / 4 fl. oz

DIN 02241810

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SUN DEFENSE SPF 30
avobenzone octinoxate oxybenzone titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63550-851
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (AVOBENZONE)	AVOBENZONE	25 mg in 1 mL
OCTINOXATE (OCTINOXATE)	OCTINOXATE	75 mg in 1 mL
OXYBENZONE (OXYBENZONE)	OXYBENZONE	6 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	20 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
OCTYLDODECYL NEOPENTANOATE
PROPYLENE GLYCOL
ACER SACCHARUM SAP
.ALPHA.-TOCOPHEROL ACETATE, D-
CETYL ALCOHOL
STEARIC ACID
DIETHANOLAMINE CETYL PHOSPHATE
PANTHENOL
DIMETHICONE
XANTHAN GUM
SODIUM HYDROXIDE
PHENOXYETHANOL
CHLORPHENESIN
BUTYLATED HYDROXYTOLUENE
FERRIC OXIDE RED

Packaging
#	Item Code	Package Description
1	NDC:63550-851-10	120 mL in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/02/2011

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Kamins Dermatologics Inc. (254050784)

Establishment
Name	Address	ID/FEI	Operations
Kamins Dermatologics Inc.		254050784	manufacture, pack, label

Revised: 09/2011

Document Id: bb4d7be9-2550-424b-80a0-b968df95e619

Set id: 018fd6aa-fa5c-4ebf-95ce-f43d3fcaccc8

Version: 1

Effective Time: 20110902

Kamins Dermatologics Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.