COPPERTONE KIDS SUNSCREEN SPF 70PLUS - avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray 
Schering-Plough HealthCare Products, Inc.

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Coppertone®
KIDS
SUNSCREEN

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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

Flammable

Do not use near heat, flame, or while smoking.

When using this product

• keep out of eyes. Rinse with water to remove.
• do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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. Do not spray directly on face. Spray into hands and apply to face. Use in well-ventilated areas. 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.
• Avoid long term storage above 40°C (104°F)

Inactive Ingredients

Alcohol Denat. (63.5% V/V), Acrylates/Octylacrylamide Copolymer, Glycerin, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Fragrance, Retinyl Palmitate (Vitamin A Palmitate), Caprylic/Capric Triglyceride

PRINCIPAL DISPLAY PANEL - 6 FL OZ Spray Can

Clear
No-Rub Spray

Coppertone®
KIDS
SUNSCREEN

with
Protective
Vitamins

70+
SPF

Continuous
Spray®

with an Antioxidant Vitamin
blend to supplement skin's
natural defenses

Broad Spectrum
UVA/UVB Protection

Waterproof

Quick and Even Coverage

6 FL OZ (177 mL)

COPPERTONE KIDS SUNSCREEN  SPF 70PLUS avobenzone, homosalate, octisalate, octocrylene, and oxybenzone   spray

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 11523-7316 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (Avobenzone) Avobenzone 26.91 mg  in 1 mL Homosalate (Homosalate) Homosalate 134.57 mg  in 1 mL Octisalate (Octisalate) Octisalate 44.86 mg  in 1 mL Octocrylene (Octocrylene) Octocrylene 89.71 mg  in 1 mL Oxybenzone (Oxybenzone) Oxybenzone 53.83 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength alcohol   Glycerin   Alpha-Tocopherol   Vitamin A Palmitate   Medium-Chain Triglycerides

Product Characteristics Color YELLOW (Clear to pale yellow) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 11523-7316-1 177 mL In 1 BOTTLE, SPRAY 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, Inc. (039137567)

Establishment
Name	Address	ID/FEI	Operations
Schering-Plough HealthCare Products, Inc.		808936293	MANUFACTURE

Revised: 06/2010Schering-Plough HealthCare Products, Inc.