Coppertone ultraGUARD description, usages, side effects, indications, overdosage, supplying and lots more!

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Coppertone ultraGUARD

Schering-Plough HealthCare Products, Inc.

Coppertone ultraGUARD


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredients

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

Coppertone ultraGUARD 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

Coppertone ultraGUARD 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

Coppertone ultraGUARD

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

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30.84 mg
HOMOSALATE Homosalate 154.2 mg
OCTISALATE OCTISALATE 51.4 mg
OCTOCRYLENE Octocrylene 102.8 mg
OXYBENZONE OXYBENZONE 61.68 mg

Inactive Ingredients

Ingredient Name Strength
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)

Packaging

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

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 1999-05-21


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