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

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Coppertone UltraGuard

MSD Consumer Care, Inc.

Coppertone UltraGuard™ SPF 50


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

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable

Do not use near heat, flame, or while smoking.

Do not use on damaged or broken skin

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 occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • do not spray directly on face. Spray into hands and apply to face
  • use in well-ventilated areas
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, sunglasses
  • children under 6 months: Ask a doctor

Coppertone UltraGuard Other information

  • may stain or damage some fabrics or surfaces
  • avoid long term storage above 40°C (104°F)
  • protect this product from excessive heat and direct sun

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

Questions? 866-288-3330

Distributed by
MSD Consumer Care, Inc.,
PO Box 377,
Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Coppertone®
SUNSCREEN CONTINUOUS SPRAY

ULTRA
GUARD™

Broad
Spectrum
SPF
50

Protection From The Most
Damaging UVA/UNB Rays

Quick and Even
Coverage

Water Resistant
(80 minutes)

50

6 FL OZ (177 mL)

Coppertone UltraGuard

Coppertone UltraGuard

Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7243
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
stearoxytrimethylsilane
GLYCERIN
Diethylhexyl Syringylidenemalonate
.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:11523-7243-1 177 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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