Copperstone Water Babies Pure And Simple Whipped Sunscreen Broad Spectrum Spf 50

Copperstone Water Babies Pure And Simple Whipped Sunscreen Broad Spectrum Spf 50
SPL v3
SPL
SPL Set ID 481e1841-a198-1de2-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (45 mg) Octocrylene (40 mg) Oxybenzone (60 mg)
Inactive Ingredients
Aluminum Starch Octenylsuccinate Water Docosanol Glycerin Dicaprylyl Ether Microcrystalline Cellulose Glyceryl Monostearate Cetyl Alcohol Benzyl Alcohol Palmitic Acid Stearic Acid Myristyl Alcohol Chlorphenesin Tocopherol Carboxymethylcellulose Sodium, Unspecified Form Edetate Disodium Anhydrous Lauryl Alcohol Sodium Ascorbyl Phosphate Nitrous Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-02-09

Description

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 4%, Oxybenzone 6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 4%, Oxybenzone 6%

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

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • do not dispense or apply directly on face. Dispense into hands and apply to face
  • use in well-ventillated areas
  • reapply:
  • after 80 minutes if swimming or sweating
  • imediately 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 sunscereen 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
Questions?

1-866-288-330

Do Not Use On 

damaged or broken skin

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

Active Ingredients

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,

Octocrylene 4%, Oxybenzone 6%

Inactive Ingredients

Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Fragrance, Nitrous Oxide.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Intentional misue 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.


Structured Label Content

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

Sunscreen

Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • do not dispense or apply directly on face. Dispense into hands and apply to face
  • use in well-ventillated areas
  • reapply:
  • after 80 minutes if swimming or sweating
  • imediately 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 sunscereen 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
Questions?

1-866-288-330

Do Not Use On  (Do not use on )

damaged or broken skin

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

Active Ingredients (Active ingredients)

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,

Octocrylene 4%, Oxybenzone 6%

Inactive Ingredients (Inactive ingredients)

Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Fragrance, Nitrous Oxide.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • use only as directed. Intentional misue 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 (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If product is swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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