COPPERTONE SPORT SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Schering-Plough HealthCare Products, Inc.

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.

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Coppertone
SPORT®

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 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

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. (72.7% V/V), Acrylates/Octylacrylamide Copolymer, Stearoxytrimethylsilane, Glycerin, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Fragrance, Retinyl Palmitate (Vitamin A Palmitate), Caprylic/Capric Triglyceride

PRINCIPAL DISPLAY PANEL - 237 mL bottle

NOW with
Replenishing
Antioxidants!

Coppertone
SPORT®
SUNSCREEN

Clear
Continuous
Spray®

50
SPF

Ultra
Sweatproof

Waterproof

Broad Spectrum
UVA/UVB Protection

Sprays at Any Angle

8 FL OZ (237 mL)

COPPERTONE SPORT SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11523-7298
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (Avobenzone)	Avobenzone	26.03 mg in 1 mL
Homosalate (Homosalate)	Homosalate	86.76 mg in 1 mL
Octisalate (Octisalate)	Octisalate	43.38 mg in 1 mL
Octocrylene (Octocrylene)	Octocrylene	34.7 mg in 1 mL
Oxybenzone (Oxybenzone)	Oxybenzone	43.38 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
glycerin
alpha-tocopherol
vitamin A palmitate
medium-chain triglycerides

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

#	Item Code	Package Description
Packaging
1	NDC:11523-7298-1	237 mL in 1 BOTTLE, SPRAY
2	NDC:11523-7298-2	222 mL in 1 BOTTLE, SPRAY

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

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

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

Revised: 12/2009

Document Id: 9301590f-d492-4933-8d08-865526b7cdcb

Set id: 195f66ce-12d8-48ca-b5e2-a7987c061379

Version: 1

Effective Time: 20091209

Schering-Plough HealthCare Products, Inc.

Coppertone SPORT®