COPPERTONE SPORT  SPF 100 PLUS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
MSD Consumer Care, 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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Drug Facts

Active ingredients

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

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and other skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

Other information

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics or surfaces

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.

Questions?

866-288-3330

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Coppertone®
SPORT®
High Performance

Sunscreen
UVA/UVB

Broad
Spectrum
SPF
100+

Stays on Strong
when you Sweat
(won't run into eyes and sting)

Plus Antioxidant Defense

Water Resistant (80 Minutes)

100+

4 FL OZ (118 mL)

37748-FC

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:11523-7325
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:11523-7325-1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/21/1999
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 08/2012
Document Id: 1dcddf26-3cab-4955-a249-bdf7fa8a5b5a
Set id: 90255897-e953-4ad4-847c-ecad273b3fe9
Version: 1
Effective Time: 20120814
 
MSD Consumer Care, Inc.