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Coppertone

MSD Consumer Care, Inc.

Coppertone SPF 15


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 5%

Purpose

Sunscreen

Coppertone 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

Other information

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

Inactive Ingredients

Water, Sorbitol, Ethylhexyl Palmitate, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Dimethicone, Tocopherol (Vitamin E), Cetyl Phosphate, Aloe Barbadensis Leaf Juice, Triethanolamine, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Disodium EDTA, Chlorphenesin

Questions?

866-288-3330

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Coppertone®

Tanning
Lotion
Sunscreen

Broad
Spectrum
SPF
15

UVA/UVB Protection

Non-Greasy,
Light Formula

Water Resistant
(80 minutes)

With Aloe
and Vitamin E

15

8 FL OZ (237 mL)

Coppertone

Coppertone

Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7335
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 20.06 mg
HOMOSALATE Homosalate 100.3 mg
OCTISALATE OCTISALATE 50.15 mg
OCTOCRYLENE Octocrylene 50.15 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
ETHYLHEXYL PALMITATE
BENZYL ALCOHOL
DIMETHICONE
.ALPHA.-TOCOPHEROL
CETYL PHOSPHATE
Aloe Vera Leaf
TROLAMINE
EDETATE DISODIUM
CHLORPHENESIN

Product Characteristics

Color
WHITE (white to light yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7335-1 237 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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