COPPERTONE KIDS SPF 50- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray 
Schering-Plough HealthCare Products, 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 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Purpose

Sunscreen

Uses

  • screens out the sun's burning rays to help prevent sunburn
  • provides protection from UVA rays that may contribute to skin damage and premature aging of the skin
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water or sweating

Warnings

For external use only

Flammable

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

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 or irritation develops and lasts

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 months of age and olderapply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Do not spray directly on face. Spray into hands and apply to face. Use in well-ventilated areas. Reapply as needed or after towel drying, swimming, perspiring, or vigorous activity.
children under 2 years of ageshould use sunscreen products with a minimum SPF of 15
children under 6 months of ageask a doctor

Other information

  • may stain some fabrics
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  • Avoid long term storage above 40°C (104°F)

Inactive ingredients

Alcohol Denat. (72.7% V/V), Acrylates/Octylacrylamide Copolymer, Stearoxytrimethylsilane, Glycerin, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Fragrance, Retinyl Palmitate (Vitamin A Palmitate), Caprylic/Capric Triglyceride

PRINCIPAL DISPLAY PANEL - 237 mL bottle

Clear
No-Rub Spray

Coppertone®

KIDS®
SUNSCREEN

with
Protective
Vitamins

Continuous
Spray®

50
SPF

with an Antioxidant Vitamin
blend to supplement skin's
natural defenses

Broad Spectrum
UVA/UVB Protection

Waterproof

Quick and Even Coverage

8 FL OZ (237 mL)

Principal Display Panel - 237 mL bottle
COPPERTONE KIDS  SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7302
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone26.03 mg  in 1 mL
Homosalate (Homosalate) Homosalate86.76 mg  in 1 mL
Octisalate (Octisalate) Octisalate43.38 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene34.7 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone43.38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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:11523-7302-1222 mL in 1 BOTTLE, SPRAY
2NDC:11523-7302-2237 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/21/1999
Labeler - Schering-Plough HealthCare Products, Inc. (039137567)
Establishment
NameAddressID/FEIBusiness Operations
Schering-Plough HealthCare Products, Inc.808936293MANUFACTURE

Revised: 12/2009
Document Id: 34d1bb8d-8ec2-4d71-943a-6b8ff3a4c648
Set id: 9f96f68a-c010-4415-bb71-b62b234c57c5
Version: 1
Effective Time: 20091208
 
Schering-Plough HealthCare Products, Inc.