COPPERTONE DEFEND AND CARE ULTRA HYDRATING SPF 50- 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 Defend & Care Ultra Hydrate Lotion SPF 50

Drug Facts

Active ingredients

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 4.55%,

Octocrylene 9 %, Oxybenzone 5%

Purpose

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

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use

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

• Shake well before use.

• 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, dimethicone, ethylhexyl isononanoate, styrene/acrylates copolymer, glycerin, octyldodecanol,

Galactoarabinan, silica, glyceryl stearate, peg-100 stearate, benzyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer,tocopherol (vitamin E), Beeswax, Chlorphenesin, disodium EDTA, sodium ascorbyl phosphate, fragrance

Questions

Questions? 1-866-288-3330

Bottle 177 mL

Bottle

COPPERTONE DEFEND AND CARE  ULTRA HYDRATING SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7388
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE31.02 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE103.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.05 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE93.06 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE51.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
GALACTOARABINAN (UNII: SL4SX1O487)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-100 STEARATE (UNII: YD01N1999R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CUPRIC BIS(TRIETHANOLAMINE) (UNII: YBM44X0B6H)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
GLYCERIN (UNII: PDC6A3C0OX)  
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:11523-7388-1177 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201708/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201708/01/2021
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2019
 
Bayer HealthCare LLC.