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Coppertone SPF 15 by Bayer HealthCare LLC

Dosage form: lotion
Ingredients: AVOBENZONE 20.06mg in 1mL, HOMOSALATE 100.3mg in 1mL, OCTISALATE 50.15mg in 1mL, OCTOCRYLENE 50.15mg in 1mL
Labeler: Bayer HealthCare LLC
NDC Code: 11523-7335

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 ®

SPF 15

Drug Facts

Active ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen

Uses

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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

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, 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, Sorbitol, Ethylhexyl Palmitate, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Dimethicone, Tocopherol (Vitamin E), Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Triethanolamine, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Disodium EDTA, Chlorphenesin

Questions?

Questions? 866-288-3330

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Coppertone ®

Tanning

Lotion

Sunscreen

Broad

Spectrum

SPF

15

UVA/UVB Protection

Non-Greasy,

Light Formula

Water Resistant

(80 minutes)

With Aloe

and Vitamin E

15

8 FL OZ (237 mL)

COPPERTONE  SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7335
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE20.06 mg  in 1 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE100.3 mg  in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE50.15 mg  in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE50.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
ETHYLHEXYL PALMITATE 
BENZYL ALCOHOL 
DIMETHICONE 
.ALPHA.-TOCOPHEROL 
CETYL PHOSPHATE 
ALOE VERA LEAF 
TROLAMINE 
EDETATE DISODIUM 
CHLORPHENESIN 
Product Characteristics
Colorwhite (white to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7335-1237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/1999
Labeler - Bayer HealthCare LLC (968091715)

Revised: 02/2016
 
Bayer HealthCare LLC

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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