COPPERTONE OIL FREE SPF 50 SUNSCREEN- avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion 
Beiersdorf 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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Coppertone Oil Free Lotion SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%

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, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-27, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

Coppertone® Sunscreen Lotion

Oil Free FACE

50

Won't clog pores or cause breaksouts

Free of oxybenzone, octinoxate, dyes & PABA

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

3 FL OZ (88 mL)

Oil Free

COPPERTONE OIL FREE SPF 50 SUNSCREEN 
avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4094
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
POLYESTER-7 (UNII: 0841698D2F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
DOCOSANOL (UNII: 9G1OE216XY)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISODODECANE (UNII: A8289P68Y2)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-4094-388 g in 1 TUBE; Type 0: Not a Combination Product04/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2022
Labeler - Beiersdorf Inc (001177906)

Revised: 3/2023
Document Id: f63d072b-a41f-cc5a-e053-2995a90a2975
Set id: ded1f158-36d1-153f-e053-2995a90ace30
Version: 2
Effective Time: 20230306
 
Beiersdorf Inc