COPPERTONE WATER BABIES  SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
MSD Consumer Care, 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® Water Babies®
SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 7%, 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

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, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA

Questions?

866-288-3330

Distributed by MSD Consumer Care, Inc.,
PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Coppertone®
SUNSCREEN LOTION

water
BABIES®

Broad
Spectrum
SPF
50

#1 PEDIATRICIAN
RECOMMENDED BRAND

Water Resistant
(80 minutes)

50

8 FL OZ (237 mL)

Principal Display Panel - 237 mL Bottle Label
COPPERTONE WATER BABIES   SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11523-7207
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30.9 mg  in 1 mL
Homosalate (Homosalate) Homosalate133.9 mg  in 1 mL
Octisalate (Octisalate) Octisalate51.5 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene72.1 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone41.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Aluminum Starch Octenylsuccinate 
Stearic Acid 
Trolamine 
Sorbitan Isostearate 
Benzyl Alcohol 
Dimethicone 
.Alpha.-tocopherol 
Methylparaben 
Propylparaben 
Edetate Disodium 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7207-1118 mL in 1 BOTTLE, PLASTIC
2NDC:11523-7207-2237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/12/1993
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 9/2012
Document Id: a588b962-245a-4ce2-87e6-5828a32a28b3
Set id: 12ddcee7-4cbe-4b3c-bc6c-cfcaf03e7b97
Version: 2
Effective Time: 20120928
 
MSD Consumer Care, Inc.