← See all Coppertone ultraGUARD SPF 50 brands

Coppertone ultraGUARD SPF 50 by Schering-Plough HealthCare Products, Inc.

Dosage form: spray
Ingredients: Avobenzone 26.03mg in 1mL, Homosalate 86.76mg in 1mL, Octisalate 43.38mg in 1mL, Octocrylene 34.7mg in 1mL, Oxybenzone 43.38mg in 1mL
Labeler: Schering-Plough HealthCare Products, Inc.
NDC Code: 11523-7323

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

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 - 222 mL Label

Clear
No-Rub Spray

Coppertone®

ultraGUARD®
sunscreen

Continuous
Spray
®

50
SPF

BROAD
SPECTRUM
UVA/UVB PROTECTION

Waterproof

Quick & Even Coverage

Sprays at Any Angle

7.5 FL OZ (222 mL)

COPPERTONE ULTRAGUARD   SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7323
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
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:11523-7323-1177 mL in 1 BOTTLE, SPRAY
2NDC:11523-7323-2222 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/FEIOperations
Schering-Plough HealthCare Products, Inc.808936293MANUFACTURE

Revised: 06/2010
 
Schering-Plough HealthCare Products, Inc.

← See all Coppertone ultraGUARD SPF 50 brands

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.

Hide
(web3)