Coppertone ® waterBABIES ® SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

COPPERTONE WATERBABIES SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol 
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 ®

SPF 50

Drug Facts

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 2%, Oxybenzone 4%

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

Flammable: Do not use near heat, flame, or while smoking.

Do not use on damaged or broken skin

When using this product

  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

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

  • shake well before each use
  • apply liberally 15 minutes before sun exposure and rub into skin
  • do not spray directly on face. Spray into hands and apply to face
  • use in well-ventilated areas
  • 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

  • may stain or damage some fabrics or surfaces
  • store between 20° to 25°C (68° to 77°F)
  • protect this product from excessive heat and direct sun

Inactive Ingredients

water, dimethyl ether, sorbitol, styrene/acrylates copolymer, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, acrylates/C10-30 alkyl acrylate crosspolymer, propylparaben, disodium EDTA

Distributed by

Bayer HealthCare LLC

Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 170 g Can Label

Coppertone ®

SUNSCREEN

water

BABIES ®

LOTION

Spray

Broad

Spectrum

SPF

50

#1 PEDIATRICIAN

RECOMMENDED BRAND

Water Resistant

(80 minutes)

50

NET WT 6 OZ (170 g)

carton label

COPPERTONE WATERBABIES SUNSCREEN  SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7231
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE130 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHYL ETHER (UNII: AM13FS69BX)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7231-1170 g in 1 CAN; Type 0: Not a Combination Product05/12/199308/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/12/199308/01/2019
Labeler - Bayer HealthCare LLC (112117283)

Revised: 8/2019
Document Id: 900523a1-f2ff-5a71-e053-2a95a90a3daf
Set id: 07e93376-9bfa-44ca-acb8-258d6822b1c6
Version: 3
Effective Time: 20190813
 
Bayer HealthCare LLC