Coppertone Defend & Care Face Oil Free Lotion SPF 50

Coppertone Defend & Care Face Oil Free Lotion SPF 50

Drug Labeling and Warnings

Drug Details

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COPPERTONE DEFEND AND CARE FACE OIL FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene 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 Defend & Care Face Oil Free Lotion SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%,

Octisalate 4.5%, Octocrylene 8%

Purpose

Sunscreen

Uses

■ helps prevent sunburn

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, and sunglasses

■ children under 6 months: Ask a doctor

Other information

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, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions? 1-866-288-3330

New &

Improved

Formula

Coppertone®

Sunscreen Lotion

Defend

& Care™

Face

Oil Free 50

Won't Clog Pores

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Label 3 oz.

COPPERTONE DEFEND AND CARE  FACE OIL FREE SPF 50
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7414
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE82.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE102.8 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE46.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISODODECANE (UNII: A8289P68Y2)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Product Characteristics
Colorwhite (Off white to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7414-188 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/2017
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 10/2017
 
Bayer HealthCare LLC.


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