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 13%, Octisalate 5%, Octocrylene 7%, Oxybenzone 4%

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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

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
  • 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

  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics or surfaces

Inactive Ingredients

Water, Sorbitol, Aluminum Starch Octenylsuccinate, VP/Eicosene Copolymer, Stearic Acid, Triethanolamine, Sorbitan Isostearate, Benzyl Alcohol, Dimethicone, Tocopherol (Vitamin E), Polyglyceryl-3 Distearate, Fragrance, Methylparaben, Carbomer, Propylparaben, Disodium EDTA

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 - 118 mL Bottle Label

Coppertone ®
SUNSCREEN LOTION

ULTRA
GUARD

Broad
Spectrum
SPF
50

Protection From The Most
Damaging UVA/UVB Rays

Non-Greasy

Water Resistant
(80 minutes)

50

4 FL OZ (118 mL)
28769-02

Coppertone ultraGUARD

Coppertone ultraGUARD

Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7206
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30.9 mg
HOMOSALATE Homosalate 133.9 mg
OCTISALATE OCTISALATE 51.5 mg
OCTOCRYLENE Octocrylene 72.1 mg
OXYBENZONE OXYBENZONE 41.2 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
ALUMINUM STARCH OCTENYLSUCCINATE
STEARIC ACID
TROLAMINE
Sorbitan Isostearate
BENZYL ALCOHOL
DIMETHICONE
.ALPHA.-TOCOPHEROL
METHYLPARABEN
PROPYLPARABEN
EDETATE DISODIUM

Product Characteristics

Color
WHITE (White to off-white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7206-1 118 in 1 BOTTLE, PLASTIC
2 NDC:11523-7206-2 237 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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