Care One 924.000/924aa

Care One 924.000/924aa
SPL v8
SPL
SPL Set ID 60cba8fb-8155-4038-8f66-cffadb676f3e
Route
TOPICAL
Published
Effective Date 2022-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (90 mg) Homosalate (1000 mg) Octisalate (202.5 mg) Octocrylene (640 mg)
Inactive Ingredients
Water Aluminum Starch Octenylsuccinate Styrene/acrylamide Copolymer (500000 Mw) Glycerin Polyester-7 Silicon Dioxide Chlorphenesin Arachidyl Alcohol Yellow Wax Benzyl Alcohol Neopentyl Glycol Diheptanoate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Docosanol Tocopherol Arachidyl Glucoside Glyceryl Monostearate Peg-100 Stearate Potassium Hydroxide Edetate Disodium Anhydrous Sodium Ascorbyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-12-01 Until 2022-01-06

Description

Avobenzone 3% Homosalate 10% Octisalate 4.5% Octocrylene 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 4.5% Octocrylene 8%

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
Section 42229-5

May stain or damage some fabrics or surfaces.

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 50

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147 1-833-992-3872

Quality guaranteed or your money back.

Warnings

For external use only

Directions
  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy from 10  a.m. -2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Do Not Use
  • on damaged or broken skin
Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Inactive Ingredients

water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

When Using This Product
  • keep out of eyes.  Rinse with water to remove
Principal Display Panel

CAREONE

Compare to Coppertone Sunscreen Lotion Sport

SPORT Sunscreen Lotion

SPF 50

UVA/UVB PROTECTION

Broad Spectrum SPF 50

  • Water resistant (80 min)
  • Oxybenzone & Octinoxate Free Formula

NET 1.5 FL OZ (44 mL)

Stop Use and Ask A Doctor If
  • rash occurs
Keep Out of Reach of Children.

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


Structured Label Content

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
Section 42229-5 (42229-5)

May stain or damage some fabrics or surfaces.

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Sport Broad Spectrum SPF 50

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147 1-833-992-3872

Quality guaranteed or your money back.

Purpose

Sunscreen

Warnings

For external use only

Directions
  • apply liberaly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especialy from 10  a.m. -2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor
Do Not Use (Do not use)
  • on damaged or broken skin
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients (active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Inactive Ingredients (inactive ingredients)

water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-7, silica, chlorphenesin, arachidyl alcohol, beeswax, benzyl alcohol, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

When Using This Product (When using this product)
  • keep out of eyes.  Rinse with water to remove
Principal Display Panel (principal display panel)

CAREONE

Compare to Coppertone Sunscreen Lotion Sport

SPORT Sunscreen Lotion

SPF 50

UVA/UVB PROTECTION

Broad Spectrum SPF 50

  • Water resistant (80 min)
  • Oxybenzone & Octinoxate Free Formula

NET 1.5 FL OZ (44 mL)

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 swallowed, get medical help or contact a Poison Control right away.


Advanced Ingredient Data


Raw Label Data

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