COPPERTONE SPORT  SPF 100 PLUS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
Schering Plough HealthCare Products

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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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

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, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Butylene Glycol,Benzyl Alcohol, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Tocopherol (Vitamin E), Diethylhexyl Syringylidenemalonate, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Triethanolamine, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Oleth-3, Fragrance, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Coppertone®
SPORT®
High Performance

Broad Spectrum
UVA/UVB
Sunscreen

100+
SPF

Ultra Sweatproof
won't run into eyes and sting

Waterproof

Plus Antioxidant
Defense for
Extreme Conditions

4 FL OZ (118 mL)

37748-FB

Principal Display Panel - 118 mL Bottle Label
COPPERTONE SPORT   SPF 100 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7332
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30.54 mg  in 1 mL
Homosalate (Homosalate) Homosalate152.7 mg  in 1 mL
Octisalate (Octisalate) Octisalate50.9 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene101.8 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone61.08 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Butyloctyl Salicylate 
Butylene Glycol 
Benzyl Alcohol 
alpha-tocopherol 
Vitamin A Palmitate 
Sodium Ascorbyl Phosphate 
Trolamine 
Edetate Disodium 
Product Characteristics
ColorWHITE (off white to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7332-1118 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 (039137567)

Revised: 12/2010
Document Id: 8f845ceb-5932-410f-9b83-c0891703f608
Set id: 74193b86-7146-4ffb-a1d2-47472bd1815a
Version: 1
Effective Time: 20101209
 
Schering Plough HealthCare Products