Coppertone ® Oil Free Faces SPF 50 Plus

Coppertone Oil Free Faces by

Drug Labeling and Warnings

Coppertone Oil Free Faces 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 SPF 50 PLUS- 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 50 Plus

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 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, Butylene Glycol, Microcrystalline Cellulose, Behenyl Alcohol, Glyceryl Stearate, Benzyl Alcohol, Palmitic Acid, Stearic Acid, Tocopherol (Vitamin E), Myristyl Alcohol, Cellulose Gum, Butylated PVP, Chlorphenesin, Lecithin, Cetyl Alcohol, Lauryl Alcohol, Disodium EDTA, Sodium Ascorbyl Phosphate

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 88 mL Bottle Label

Coppertone ®

SUNSCREEN LOTION

OIL FREE

FACES

WON'T CAUSE

BREAKOUTS

Broad

Spectrum

SPF

50+

Lightweight and

Fast Absorbing

Won't Clog Pores

Dermatologist

Recommended Brand

50+

3 FL OZ (88 mL)

Bottle label

COPPERTONE OIL FREE FACES  SPF 50 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7350
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.63 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE153.15 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.05 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE102.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE61.26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PALMITIC ACID (UNII: 2V16EO95H1)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Product Characteristics
Colorwhite (Off White to Pale Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7350-188 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/201312/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201312/01/2019
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 12/2017
 
Bayer HealthCare LLC.