COPPERTONE KIDS SUNSCREEN  SPF 70PLUS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray 
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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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

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.
  • 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

  • apply liberally 15 minutes before sun exposure
  • 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
  • avoid long term storage above 40°C (104°F)
  • protect this product from excessive heat and direct sun

Inactive Ingredients

Alcohol Denat. (63.5% V/V), Acrylates/Octylacrylamide Copolymer, Glycerin, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Fragrance, Retinyl Palmitate (Vitamin A Palmitate), Caprylic/Capric Triglyceride

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 - 177 mL Bottle Label

Coppertone®
SUNSCREEN CONTINUOUS SPRAY

kids

Broad
Spectrum
SPF
70+

#1 PEDIATRICIAN
RECOMMENDED BRAND

Won't Run Into
Eyes And Sting

Water Resistant
(80 minutes)

70+

6 FL OZ (177 mL)

Principal Display Panel - 177 mL Bottle Label
COPPERTONE KIDS SUNSCREEN   SPF 70PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7316
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone26.91 mg  in 1 mL
Homosalate (Homosalate) Homosalate134.57 mg  in 1 mL
Octisalate (Octisalate) Octisalate44.86 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene89.71 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone53.83 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
alcohol 
glycerin 
.Alpha.-Tocopherol 
Vitamin A Palmitate 
Medium-Chain Triglycerides 
Product Characteristics
ColorYELLOW (clear to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7316-1177 mL in 1 BOTTLE, SPRAY
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: 07/2012
Document Id: 876c2d3b-ec93-448f-9384-5bf12ef53e29
Set id: 5ef3d38d-837d-4cd5-b04c-3fc27cdc1ecb
Version: 2
Effective Time: 20120726
 
MSD Consumer Care, Inc.