Care One D39.000/d39aa

Care One D39.000/d39aa
SPL v4
SPL
SPL Set ID 232ab407-1903-45d8-a2b2-6992ffd30d00
Route
TOPICAL
Published
Effective Date 2025-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg)
Inactive Ingredients
Water Diethylhexyl 2,6-naphthalate Aluminum Starch Octenylsuccinate Styrene/acrylamide Copolymer (500000 Mw) Butyloctyl Salicylate Glycerin Polyester-7 Silicon Dioxide Chlorphenesin Benzyl Alcohol Arachidyl Alcohol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Neopentyl Glycol Diheptanoate Docosanol Tocopherol Yellow Wax Arachidyl Glucoside Potassium Hydroxide Glyceryl Monostearate Peg-100 Stearate Edetate Disodium Anhydrous Sodium Ascorbyl Phosphate .alpha.-amylcinnamaldehyde

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-27

Description

Avobenzone 3% Homosalate 10% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5%

Uses
  • 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 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
Disclaimers

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ® Sunscreen Lotion Sport Broad Spectrum SPF 30.

May stain or damage some fabrics or surfaces.

Adverse Reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Empty Before Recycling

PLASTIC BOTTLE

how2recycle.info

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Inactive Ingredients

water, diethylhexyl 2,6-naphthalate, aluminum starch octenylsuccinate, styrene/acrylates copolymer, butyloctyl salicylate, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, amyl cinnamal

Principal Display Panel

CAREone ®

Compare to Coppertone ®Sunscreen Lotion Sport SPF 30*

SPORT

Sunscreen Lotion

SPF 30

UVA/UVB SUNCREEN

Broad Spectrum SPF 30

  • Water resistant (80 min)
  • Won't run when you start to sweat

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

Uses
  • 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 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
Disclaimers

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ® Sunscreen Lotion Sport Broad Spectrum SPF 30.

May stain or damage some fabrics or surfaces.

Adverse Reaction (Adverse reaction)

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

For product questions or concerns, contact us at 1-833-992-3872

Quality guaranteed or your money back.

Empty Before Recycling

PLASTIC BOTTLE

how2recycle.info

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 5%

Inactive Ingredients (Inactive ingredients)

water, diethylhexyl 2,6-naphthalate, aluminum starch octenylsuccinate, styrene/acrylates copolymer, butyloctyl salicylate, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, amyl cinnamal

Principal Display Panel (Principal display panel)

CAREone ®

Compare to Coppertone ®Sunscreen Lotion Sport SPF 30*

SPORT

Sunscreen Lotion

SPF 30

UVA/UVB SUNCREEN

Broad Spectrum SPF 30

  • Water resistant (80 min)
  • Won't run when you start to sweat

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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