Coppertone Water BABIES SPF 55

Dosage form: stick
Ingredients: Avobenzone 30mg in 1g, Homosalate 150mg in 1g, Octisalate 50mg in 1g, Octocrylene 100mg in 1g, Oxybenzone 60mg in 1g
Labeler: MSD Consumer Care, Inc.
NDC Code: 11523-7310

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.

Coppertone® Water BABIES®
SPF 55

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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

Beeswax, Lauryl Laurate, Ozokerite, Cetearyl Behenate, Polybutene, Cetyl Alcohol, Styrene/Acrylates Copolymer, Myristyl Myristate, Tocopherol (Vitamin E), Theobroma Cacao (Cocoa) Seed Butter, Phenoxyethanol, Retinyl Palmitate (Vitamin A Palmitate),Tetrahexyldecyl Ascorbate

Questions?

866-288-3330

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

PRINCIPAL DISPLAY PANEL - 17g Blister Pack

Coppertone®
SUNSCREEN STICK

water
BABIES®

Broad
Spectrum
SPF
55

#1
PEDIATRICIAN
RECOMMENDED
BRAND

Water Resistant
(80 minutes)

55

NET WT
0.6 OZ (17g)

COPPERTONE WATER BABIES   SPF 55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7310
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30 mg  in 1 g
Homosalate (Homosalate) Homosalate150 mg  in 1 g
Octisalate (Octisalate) Octisalate50 mg  in 1 g
Octocrylene (Octocrylene) Octocrylene100 mg  in 1 g
Oxybenzone (Oxybenzone) Oxybenzone60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
yellow wax 
lauryl laurate 
cetearyl behenate 
cetyl alcohol 
myristyl myristate 
.alpha.-tocopherol 
cocoa butter 
phenoxyethanol 
vitamin A palmitate 
tetrahexyldecyl ascorbate 
Product Characteristics
ColorWHITE (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7310-21 TUBE (TUBE) in 1 BLISTER PACK
1NDC:11523-7310-117 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/21/1999
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 04/2012
 
MSD Consumer Care, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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