Care One D56.000/d56aa

Care One D56.000/d56aa
SPL v3
SPL
SPL Set ID 3a4d1971-870c-474b-b50a-36ce6299328e
Route
TOPICAL
Published
Effective Date 2025-08-20
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
Alcohol Diethylhexyl 2,6-naphthalate Acrylate/isobutyl Methacrylate/n-tert-octylacrylamide Copolymer (40000 Mw) Diisopropyl Adipate Neopentyl Glycol Diheptanoate Butyloctyl Salicylate Linalool, (+/-)- .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-09

Description

Avobenzone 3% Homosalate 10% Octisalate 5%

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • 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
Purpose

Sunscreen

Dosage and Administration
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area and avoid inhalation
  • 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
Description

Avobenzone 3% Homosalate 10% Octisalate 5%

Flammable
  • Flammable: keep away from fire or flame. 
  • After application, wait until product dries before approaching a source of heat or flame, or before smoking
Disclaimer

May stain or damage some fabrics or surfaces

*This product is not being compared to Coppertone ® Complete Sunscreen Spray SPF 30 for any other purposes and this product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Spray SPF 30.

Do Not Use

on damaged or broken skin

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

METAL CAN

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

alcohol denat., diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, fragrance, linalool, tocopheryl acetate

Principal Panel Display

CAREone ®

Compare to the SPF of Coppertone ®Broad Spectrum SPF 30*

SUNSCREEN SPRAY

SPF 30

UVA/UVB SUNSCREEN

Broad Spectrum SPF 30

  • Water resistant (80 min)
  • Hypoallergenic

NET WT 5.5 OZ (156 g) 

When Using This Product
  • keep out of eyes. Rinse with water to remove.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 
  • rash occurs

Structured Label Content

Indications and Usage (34067-9)
  • 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
Dosage and Administration (34068-7)
  • spray liberally and spread evenly by hand 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • hold container 4 to 6 inches from the skin to apply
  • do not spray directly into face. Spray on hands then apply to face.
  • do not apply in windy conditions
  • use in a well-ventilated area and avoid inhalation
  • 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
Warnings and Precautions (34071-1)

For external use only

Purpose

Sunscreen

Flammable
  • Flammable: keep away from fire or flame. 
  • After application, wait until product dries before approaching a source of heat or flame, or before smoking
Disclaimer

May stain or damage some fabrics or surfaces

*This product is not being compared to Coppertone ® Complete Sunscreen Spray SPF 30 for any other purposes and this product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Complete Sunscreen Spray SPF 30.

Do Not Use (Do not use)

on damaged or broken skin

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

METAL CAN

how2recycle.info

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

alcohol denat., diethylhexyl 2,6-naphthalate, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, fragrance, linalool, tocopheryl acetate

Principal Panel Display (Principal panel display)

CAREone ®

Compare to the SPF of Coppertone ®Broad Spectrum SPF 30*

SUNSCREEN SPRAY

SPF 30

UVA/UVB SUNSCREEN

Broad Spectrum SPF 30

  • Water resistant (80 min)
  • Hypoallergenic

NET WT 5.5 OZ (156 g) 

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
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.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )
  • rash occurs

Advanced Ingredient Data


Raw Label Data

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