COPPERTONE  SPF 15 - avobenzone, homosalate, octisalate and octocrylene lotion 
Schering Plough HealthCare Products

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Coppertone®
Tanning
Lotion

Drug Facts

Active ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen

Uses

• screens out the sun's burning rays to help prevent sunburn
• provides protection from UVA rays that may contribute to skin damage and premature aging of the skin
• 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

adults and children 6 months of age and older	apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after towel drying, swimming, perspiring, or vigorous activity.
children under 2 years of age	should use sunscreen products with a minimum SPF of 15
children under 6 months of age	ask a doctor

Other information

• may stain some fabrics
• 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, bis-stearyl ethylenediamine/neopentyl glycol/stearyl hydrogenated dimer dilinoleate copolymer, benzyl alcohol, dimethicone, tocopherol (vitamin E), cetyl phosphate, aloe barbadensis leaf juice, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, carbomer, disodium EDTA, chlorphenesin.

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

New!

Coppertone®
Tanning
Lotion

SPF
15
Classic Scent
Sunscreen

Non-greasy,
Light Formula

Moisturizing Formula
with Aloe & Vitamin E

Waterproof

Broad Spectrum
UVA/UVB Protection

8 FL OZ (237 mL)

COPPERTONE   SPF 15 avobenzone, homosalate, octisalate, and octocrylene   lotion

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11523-7335 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (Avobenzone) Avobenzone 20.06 mg  in 1 mL Homosalate (Homosalate) Homosalate 100.3 mg  in 1 mL Octisalate (Octisalate) Octisalate 50.15 mg  in 1 mL Octocrylene (Octocrylene) Octocrylene 50.15 mg  in 1 mL

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

Product Characteristics Color WHITE (White to light yellow) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11523-7335-1 237 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