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Coppertone

MSD Consumer Care, Inc.

Coppertone SPF 4


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Octinoxate 3%, Octocrylene 2%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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
  • children under 6 months: Ask a doctor

Coppertone Other information

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

Inactive Ingredients

Water, Ethylhexyl Palmitate, Propylene Glycol, Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Tocopherol (Vitamin E), Aloe Barbadensis Leaf Extract, Diazolidinyl Urea, Methylparaben, Fragrance, Carbomer, Propylparaben, Disodium EDTA

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 - 237 mL Bottle Label

Coppertone ®

Tanning
Lotion
Sunscreen

SPF
4

Non-Greasy, Light Formula

Water Resistant
(80 minutes)

With Aloe
and Vitamin E

4

8 FL OZ (237 mL)

Coppertone

Coppertone

Octinoxate and Octocrylene LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7288
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 28.95 mg
OCTOCRYLENE Octocrylene 19.3 mg

Inactive Ingredients

Ingredient Name Strength
water
ETHYLHEXYL PALMITATE
propylene glycol
CETYL PHOSPHATE
TROLAMINE
.ALPHA.-TOCOPHEROL
Aloe Vera Leaf
DIAZOLIDINYL UREA
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:11523-7288-1 237 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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