COPPERTONE ULTRAGUARD SPF 90 PLUS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
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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Coppertone®
ultraGUARD®

Drug Facts

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, Propylene Glycol, Styrene/Acrylates Copolymer, 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- 177 mL bottle

Coppertone®

ultraGUARD®
sunscreen lotion

90+
SPF

BROAD
SPECTRUM
UVA/UVB PROTECTION

Waterproof

Photostable

Moisturizing

6 FL OZ (177 mL)

COPPERTONE ULTRAGUARD SPF 90 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:11523-7296
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (Avobenzone)	Avobenzone	30.84 mg in 1 mL
Homosalate (Homosalate)	Homosalate	154.2 mg in 1 mL
Octisalate (Octisalate)	Octisalate	51.4 mg in 1 mL
Octocrylene (Octocrylene)	Octocrylene	102.8 mg in 1 mL
Oxybenzone (Oxybenzone)	Oxybenzone	61.68 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water
Propylene Glycol
Docosanol
Glyceryl Monostearate
Cellulose, Microcrystalline
Benzyl Alcohol
Palmitic Acid
Myristyl Alcohol
Stearic Acid
Cetyl Alcohol
Vitamin A Palmitate
Alpha-Tocopherol
Sodium Ascorbyl Phosphate
Chlorphenesin

Product Characteristics
Color	WHITE (white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7296-1	177 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/21/1999

Labeler - Schering-Plough HealthCare Products, Inc. (039137567)

Revised: 12/2009

Document Id: 16284a8b-b6c7-4ec3-a22d-69ec536a06dc

Set id: d4935fb5-a69e-45b0-be53-9b9e238213eb

Version: 1

Effective Time: 20091209

Schering-Plough HealthCare Products, Inc.