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Coppertone Dry SPF 10

Dosage form: oil
Ingredients: Homosalate 42.2mg in 1mL, Octinoxate 63.3mg in 1mL, Octisalate 42.2mg in 1mL, Oxybenzone 25.32mg in 1mL
Labeler: MSD Consumer Care, Inc.
NDC Code: 11523-7340

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.

Coppertone® Dry Oil
SPF 10

Drug Facts

Active ingredients

Homosalate 5%, Octinoxate 7.5%, Octisalate 5% and Oxybenzone 3%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Flammable

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

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
  • do not spray directly on face. Spray into hands and apply to face
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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
  • avoid long term storage above 40°C (104°F)

Inactive Ingredients

alcohol denat. (80.6% V/V), acrylates/octylacrylamide copolymer, mineral oil, fragrance

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 - 177 mL Bottle Label

Coppertone®
Tanning
Dry Oil
Pump Spray

SPF 10
Classic Scent
Sunscreen

Enjoy Instant
Radiance

Ultra Light
Water Resistant
(80 minutes)

6 FL OZ (177 mL)

28640-FB

COPPERTONE DRY   SPF 10
homosalate, octinoxate, octisalate, and oxybenzone oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7340
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Homosalate (Homosalate) Homosalate42.2 mg  in 1 mL
Octinoxate (Octinoxate) Octinoxate63.3 mg  in 1 mL
Octisalate (Octisalate) Octisalate42.2 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone25.32 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
mineral oil 
Product Characteristics
ColorYELLOW (clear to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7340-1177 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/2012
Labeler - MSD Consumer Care, Inc. (968091715)
Establishment
NameAddressID/FEIOperations
Access Business Group LLC839830713MANUFACTURE

Revised: 03/2012
Document Id: 394a77de-88b0-4594-89ee-ca181f761135
Set id: 2e6febb0-2bde-41cd-8234-9c0599fe3698
Version: 1
Effective Time: 20120302
 
MSD Consumer Care, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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