COPPERTONE SPF 8 - octinoxate and octocrylene lotion
Schering Plough HealthCare Products

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Coppertone®
Tanning
Lotion

Drug Facts

Active ingredients

Octinoxate 7%, Octocrylene 3%

Purpose

Sunscreen

Uses

helps prevent sunburn
higher SPF gives more sunburn protection
retains SPF after 80 minutes of activity in the water or sweating

Warnings

For external use only

When using this product keep out of eyes. Rinse with water to remove.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply frequently or after towel drying, swimming, perspiring, or vigorous activity.
children under 6 months of age: ask a doctor

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.

Inactive Ingredients

Water, Sorbitol, Ethylhexyl Palmitate, Benzyl Alcohol, Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone, Tocopherol (Vitamin E), Triethanolamine, Aloe Barbadensis Leaf Extract, Fragrance, Carbomer, Chlorphenesin, Disodium EDTA

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

New
Look!

Coppertone®
Tanning
Lotion

SPF 8
Classic Scent
Sunscreen

Non-greasy,
Light Formula

Moisturizing Formula
with Aloe & Vitamin E

Waterproof

UVA/UVB Protection

8 FL OZ (237 mL)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

COPPERTONE SPF 8
octinoxate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	NDC Product Code (Source)	11523-7334
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (Octinoxate)	Octinoxate	70.175 mg in 1 mL
Octocrylene (Octocrylene)	Octocrylene	30.075 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Sorbitol
Ethylhexyl Palmitate
Benzyl Alcohol
Cetyl Phosphate
Dimethicone
Alpha-Tocopherol
Trolamine
Aloe Vera Leaf
Chlorphenesin
Edetate Disodium

Product Characteristics
Color	WHITE (White to off white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	11523-7334-1	237 mL In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/21/1999

Labeler - Schering Plough HealthCare Products (039137567)

Revised: 12/2010Schering Plough HealthCare Products