Coppertone ultraGUARD Sunscreen SPF 100plus

Dosage form: lotion
Ingredients: Avobenzone 30.06mg in 1mL, Homosalate 150.3mg in 1mL, Octisalate 50.1mg in 1mL, Octocrylene 100.2mg in 1mL, Oxybenzone 60.12mg in 1mL
Labeler: Schering-Plough HealthCare Products, Inc.
NDC Code: 11523-7318

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®
ultraGUARD®
sunscreen lotion

Active ingredients

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

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

  • When using this product keep out of eyes. Rinse with water to remove.

  • 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 older: apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after towel drying, swimming, perspiring, or vigorous activity.
  • Children under 2 years of age: should use sunscreen products with a minimum SPF of 15
  • Children under 6 months of age: ask 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.

Inactive Ingredients

Water, Styrene/Acrylates Copolymer, Propylene Glycol, Behenyl Alcohol, Glyceryl Stearate, Microcrystalline Cellulose, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Palmitic Acid, Myristyl Alcohol, Stearic Acid, Hydrolyzed Wheat Protein/PVP Crosspolymer, Lauryl Alcohol, Cetyl Alcohol, Retinyl Palmitate (Vitamin A Palmitate), Tocopherol (Vitamin E), Sodium Ascorbyl Phosphate, Lecithin, Cellulose Gum, Chlorphenesin, Fragrance, Butylated PVP, Disodium EDTA

PRINCIPAL DISPLAY PANEL - 6 FL OZ Bottle

Coppertone®
ultraGUARD®
sunscreen lotion

100+
SPF

BROAD
SPECTRUM
UVA/UVB PROTECTION

Waterproof
Photostable
Moisturizing

6 FL OZ (177 mL)

COPPERTONE ULTRAGUARD SUNSCREEN   SPF 100PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7318
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone30.06 mg  in 1 mL
Homosalate (Homosalate) Homosalate150.3 mg  in 1 mL
Octisalate (Octisalate) Octisalate50.1 mg  in 1 mL
Octocrylene (Octocrylene) Octocrylene100.2 mg  in 1 mL
Oxybenzone (Oxybenzone) Oxybenzone60.12 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Docosanol 
Glyceryl Monostearate 
Cellulose, Microcrystalline 
Benzyl Alcohol 
Palmitic Acid 
Myristyl Alcohol 
Stearic Acid 
Lauryl Alcohol 
Cetyl Alcohol 
Vitamin A Palmitate 
Alpha-Tocopherol 
Sodium Ascorbyl Phosphate 
Carboxymethylcellulose Sodium 
Chlorphenesin 
Edetate Disodium 
Product Characteristics
ColorWHITE (white to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-7318-1177 mL in 1 BOTTLE, PLASTIC
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)

Revised: 06/2010
 
Schering-Plough HealthCare Products, 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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