Care One 950.000/950aa

Care One 950.000/950aa
SPL v6
SPL
SPL Set ID 1dc325bb-d520-4897-b8f8-3f0ecba2274c
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) Docosanol Glyceryl Monostearate Benzyl Alcohol Peg-100 Stearate Polyester-7 Tocopherol Arachidyl Alcohol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Arachidyl Glucoside Chlorphenesin Yellow Wax Silicon Dioxide Neopentyl Glycol Diheptanoate Potassium Hydroxide Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-08

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%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (See Directions ), decreases the rist of skin cancer and early skin aging caused by the sun
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
Adverse Reaction

May stain or damage some fabrics or surfaces

Dist by Foodhold USA, LLC Landover, MD 20733  1877-846-9949

(c)2019 S&S Brands, LLC Quality guaranteed or your money back

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Water Babies Pure & Simple Broad spectrum SPF 50

**Oxybenzone & Octinoxate free

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

Principal Display Panel

CareOne

Compare to Coppertone Sunscreen Lotion Water Babies SPF 50*

Baby

Sunscreen Lotion

SPF 50

UVA/UVB protection

Broad Spectrum SPF 50

  • Water resistant (80 minutes)

Reef friendly**

8 FL OZ (236 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 Center right away.


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (See Directions ), decreases the rist of skin cancer and early skin aging caused by the sun
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
Adverse Reaction (ADVERSE REACTION)

May stain or damage some fabrics or surfaces

Dist by Foodhold USA, LLC Landover, MD 20733  1877-846-9949

(c)2019 S&S Brands, LLC Quality guaranteed or your money back

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Water Babies Pure & Simple Broad spectrum SPF 50

**Oxybenzone & Octinoxate free

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

Principal Display Panel (Principal display panel)

CareOne

Compare to Coppertone Sunscreen Lotion Water Babies SPF 50*

Baby

Sunscreen Lotion

SPF 50

UVA/UVB protection

Broad Spectrum SPF 50

  • Water resistant (80 minutes)

Reef friendly**

8 FL OZ (236 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 Center right away.


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Raw Label Data

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