Care One 940.000/940aa

Care One 940.000/940aa
SPL v9
SPL
SPL Set ID e430b830-6d8d-42cc-9889-a74b0092cdfa
Route
TOPICAL
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (45 mg) Octocrylene (80 mg)
Inactive Ingredients
Water Glycerin Aluminum Starch Octenylsuccinate Styrene/acrylamide Copolymer (500000 Mw) Polyester-7 Silicon Dioxide Chlorphenesin Arachidyl Alcohol Yellow Wax Neopentyl Glycol Diheptanoate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Docosanol Tocopherol Arachidyl Glucoside Glyceryl Monostearate Peg-100 Stearate Potassium Hydroxide Benzyl Alcohol Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-08

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%

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

For external use only

Directions

■ apply liberally {and evenly} 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 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-sleeved shirts, pants, hats and sunglasses

■ children under 6 months of age: Ask a doctor

Do Not Use
  • on damaged or broken skin
Adverse Reaction

May stain or damage some fabrics or surfaces

Dist by Foolhold USA, LLC

Landover, MD 20785 1-877-848-8949

(c) S&S Brands, LLC

Quality guraranteed or your money back.

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.

**Oxybenzone & Octinoxate Free

Other Information
  • Protect the product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Inactive Ingredients

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

Principal Panel Display

Care One

Compare to Coppertone sunscreen Lotion Ultra Guard SPF 50*

SUNSCREEN LOTION

SPF 50 UVA/UVB protection

BROAD SPECTRUM SPF 50

  • Water-Resistand (80 minutes)
  • Enriched with moisturizers
  • Hypoallergenic

Reef friendly**

8 FL OZ (236 mL)

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


Structured Label Content

Use
  • helps prevent sunburn
  • if used as directed with other sun protections measures (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 {and evenly} 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 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-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
Adverse Reaction (ADVERSE REACTION)

May stain or damage some fabrics or surfaces

Dist by Foolhold USA, LLC

Landover, MD 20785 1-877-848-8949

(c) S&S Brands, LLC

Quality guraranteed or your money back.

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.

**Oxybenzone & Octinoxate Free

Other Information (Other information)
  • Protect the product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Inactive Ingredients (Inactive ingredients)

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

Principal Panel Display

Care One

Compare to Coppertone sunscreen Lotion Ultra Guard SPF 50*

SUNSCREEN LOTION

SPF 50 UVA/UVB protection

BROAD SPECTRUM SPF 50

  • Water-Resistand (80 minutes)
  • Enriched with moisturizers
  • Hypoallergenic

Reef friendly**

8 FL OZ (236 mL)

When Using This Product (When using this product)
  • keep out of eyes.  Rinse with water to remove.
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 Center right away.


Advanced Ingredient Data


Raw Label Data

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