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

Coppertone Water Babies

MSD Consumer Care, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Coppertone Water Babies Foaming Sunscreen SPF 75 Plus

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

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.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • 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

  • shake well before use
  • apply liberally 15 minutes before sun exposure and rub into skin
  • 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, and sunglasses
  • children under 6 months: Ask a doctor

Other information

  • may stain or damage some fabrics or surfaces
  • store between 20° to 25°C (68° to 77°F)
  • protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Isobutane, Sorbitol, Styrene/Acrylates Copolymer, VP/Eicosene Copolymer, Stearic Acid, Benzyl Alcohol, Triethanolamine, Dimethicone, Sorbitan Isostearate, Tocopherol (Vitamin E), Chlorphenesin, Aloe Barbadensis Leaf Extract, Polyglyceryl-3 Distearate, Ethylhexyl Palmitate, Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A Palmitate), Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, 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 - 170 g Can Label

Foaming
LOTION

Coppertone®
SUNSCREEN

water
BABIES®
Foaming
LOTION

Broad
Spectrum
SPF
75+

#1 PEDIATRICIAN
RECOMMENDED BRAND

Water Resistant
(80 minutes)

75+

NET WT 6 OZ (170 g)

PRINCIPAL DISPLAY PANEL - 170 g Can Label

Coppertone Water Babies

Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:11523-7324
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 30 mg
HOMOSALATE Homosalate 150 mg
OCTISALATE OCTISALATE 50 mg
OCTOCRYLENE Octocrylene 100 mg
OXYBENZONE OXYBENZONE 60 mg

Inactive Ingredients

Ingredient Name Strength
water
isobutane
sorbitol
STEARIC ACID
BENZYL ALCOHOL
TROLAMINE
DIMETHICONE
Sorbitan Isostearate
Tocopherol
CHLORPHENESIN
Aloe Vera Leaf
ETHYLHEXYL PALMITATE
SODIUM ASCORBYL PHOSPHATE
VITAMIN A PALMITATE
EDETATE DISODIUM

Product Characteristics

Color
WHITE (off white to light yellow)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:11523-7324-1 170 in 1 CAN

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 1999-05-12


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