Coppertone® waterBABIES® Pure & Simple Free SPF 50 UI 1612519

Coppertone® waterBABIES® Pure & Simple Free SPF 50 UI 1612519

Drug Labeling and Warnings

Drug Details

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COPPERTONE WATERBABIES PURE AND SIMPLE FREE SPF 50- avobenzone, homosalate, octisalate, octocrylene, 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® waterBABIES® Pure & Simple Free SPF 50 UI 1612519

Drug Facts

Drug Facts

Active Ingredients

Active Ingredients Purpose

Avobenzone 3%, Homosalate 15%, Octisalate 5%,

Octocrylene 10%, Oxybenzone 6%.............................Sunscreen

Use

  • helps prevent sunburn

Warnings

For external use only

Do not use

Do not use on damaged or broken skin

When Using this Product

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

Stop use and ask a doctor

Stop use and ask a doctor if a rash occurs

Keep out of reach of children.

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 Specturm SPF value of 15 or higher and other sun protection measures including: limit the 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?

Questions? 1-866-288-3330

Label 6 oz.

New Look

Coppertone®

SUNSCREEN LOTION

water

babies®

Pure & Simple

No Frangrance,

Parabens, PABA 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

6 FL OZ (177 mL)

6 oz bottle label

COPPERTONE WATERBABIES PURE AND SIMPLE FREE  SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7409
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE153.15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE102.1 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.63 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.05 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE61.26 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DOCOSANOL (UNII: 9G1OE216XY)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PALMITIC ACID (UNII: 2V16EO95H1)  
LAURYL ALCOHOL (UNII: 178A96NLP2)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
MYRISTYL ALCOHOL (UNII: V42034O9PU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
Product Characteristics
Colorwhite (WHITE TO OFF-WHITE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7409-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/1999
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 1/2018
 
Bayer HealthCare LLC.


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