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 sunscreen


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%

Purpose

Sunscreen

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

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 older apply 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 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.
  • 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

Coppertone ultraGUARD

Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7323
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 26.03 mg
HOMOSALATE Homosalate 86.76 mg
OCTISALATE OCTISALATE 43.38 mg
OCTOCRYLENE Octocrylene 34.7 mg
OXYBENZONE OXYBENZONE 43.38 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
GLYCERIN
ALPHA-TOCOPHEROL
VITAMIN A PALMITATE
MEDIUM-CHAIN TRIGLYCERIDES

Product Characteristics

Color
YELLOW (Clear to pale yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7323-1 177 in 1 BOTTLE, SPRAY
2 NDC:11523-7323-2 222 in 1 BOTTLE, SPRAY

Marketing Information

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


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