Coppertone ® oil free faces SPF 30

Coppertone oil free faces Sunscreen by

Drug Labeling and Warnings

Coppertone oil free faces Sunscreen by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COPPERTONE OIL FREE FACES SUNSCREEN SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion 
Bayer HealthCare LLC

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 ® oil free faces

SPF 30

Drug Facts

Active ingredients

Avobenzone 2%, Homosalate 13%, Octisalate 5%, Octocrylene 2%, and Oxybenzone 4%

Purpose

Sunscreen

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

  • 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, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, triethanolamine, stearic acid, sorbitan isostearate, benzyl alcohol, dimethicone, polyglyceryl-3 distearate, tocopherol (vitamin E), carbomer, methylparaben, propylparaben, disodium EDTA

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

Coppertone ®

oil

free

Sunscreen Lotion

faces

fragrance free

hypoallergenic won't clog pores

Broad

Spectrum

SPF

30

Pure & Simple

Sun Protection

30

3 FL OZ (88 mL)

Coppertone Faces SPF 30 label

COPPERTONE OIL FREE FACES SUNSCREEN  SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20.7 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE134.55 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.75 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20.7 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE41.4 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
TROLAMINE (UNII: 9O3K93S3TK)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Colorwhite (White to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7141-188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/199912/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/199912/01/2019
Labeler - Bayer HealthCare LLC (112117283)

Revised: 8/2019
Document Id: 8f6126a6-63a9-9b0f-e053-2995a90a8890
Set id: b57bb873-5874-4a9e-bba1-22d5892d9b5e
Version: 3
Effective Time: 20190805
 
Bayer HealthCare LLC