COPPERTONE SPORT SUNSCREEN  SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
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®
SUNSCREEN

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 5%, 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 premautre 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 olderapply 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 ageshould use sunscreen products with a minimum SPF of 15
children under 6 months of ageask 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, Styrene/Acrylates Copolymer, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Triethanolamine, Chlorphenesin, Fragrance, Oleth-3, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 32 FL OZ Bottle

Now with
Replenishing
Antioxidants!

Coppertone
SPORT®
SUNSCREEN

50
SPF

Ultra
Sweatproof
won't run into eyes and sting

Waterproof

Broad Spectrum
UVA/UVB Protection

No Slip Grip
ultra dry formula

32 FL OZ (946mL)

Principal Display Panel
COPPERTONE SPORT SUNSCREEN   SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7322
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30.3 mg  in 1 mL
Homosalate (Homosalate) Homosalate131.3 mg  in 1 mL
Octisalate (Octisalate) Octisalate50.5 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene50.5 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone60.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Benzyl Alcohol 
Alpha-Tocopherol 
Sodium Ascorbyl Phosphate 
Vitamin A Palmitate 
Trolamine 
Chlorphenesin 
Medium-Chain Triglycerides 
Edetate Disodium 
Product Characteristics
ColorWHITE (white to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7322-5946 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/21/1999
Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

Revised: 6/2010
Document Id: c17092dc-073c-4a7c-b1e6-8476ec45e007
Set id: 54272a64-e2f0-4493-a44a-031eda87ea69
Version: 1
Effective Time: 20100609
 
Schering-Plough HealthCare Products, Inc.