care one 929.001 929ab

care one 929.001 929ab
SPL v8
SPL
SPL Set ID 7facc1f1-3627-4c8b-9a3b-9ceabb8d7946
Route
topical
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (150 mg) octisalate (50 mg) octocrylene (80 mg) avobenzone (30 mg)
Inactive Ingredients
alcohol stearoxytrimethylsilane glycerin trolamine tocopherol butyloctyl salicylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-01-06

Purpose

sunscreen

Description

Avobenzone 3% Homosalate 15%  Octisalate 5% Octocrylene 8%


Medication Information

Warnings

For external use only

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

Purpose

sunscreen

Directions

■ 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

Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, triethanolamine, tocopherol, butyloctyl salicylate, fragrance

Description

Avobenzone 3% Homosalate 15%  Octisalate 5% Octocrylene 8%

Principal Display Panel

CAREONE ®

Compare to Coppertone ®KIDS Broad Spectrum SPF 50*

KIDS

Sunscreen Spray

SPF

50

UVA/UVB PROTECTION

Broad Spectrum SPF 50

  • Water resistant (80 min)

REEF FRIENDLY**

NET WT 5.5 OZ (156 g)

Flammable

Keep away from fire or flame.

  • after application, wait until product dries before approaching a source of heat or flame, or before smoking
Do Not Use 
  • on damaged or broken skin
Adverse Reaction

May stain or damage some fabrics of surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray KIDS Broad Spectrum SPF 50.

**Oxybenzone & Octinoxate free

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

©2021 Ahold Delhaize Licensing Sarl

Quality guaranteed or your money back.

Active Ingredients

Avobenzone 3%

Homosalate 15% 

Octisalate 5%

Octocrylene 8%

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 120ºF.
Stop Use and Ask A Doctor If
  • rash occurs
Keep Out of Reach of Children

if swallowed, get medical help or contact a Poison Conrol Center right away


Structured Label Content

Warnings (warnings)

For external use only

Uses (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

Purpose (purpose)

sunscreen

Directions (directions)

■ 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

Other Information (other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (inactive ingredients)

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, triethanolamine, tocopherol, butyloctyl salicylate, fragrance

Principal Display Panel (principal display panel)

CAREONE ®

Compare to Coppertone ®KIDS Broad Spectrum SPF 50*

KIDS

Sunscreen Spray

SPF

50

UVA/UVB PROTECTION

Broad Spectrum SPF 50

  • Water resistant (80 min)

REEF FRIENDLY**

NET WT 5.5 OZ (156 g)

Flammable

Keep away from fire or flame.

  • after application, wait until product dries before approaching a source of heat or flame, or before smoking
Do Not Use  (do not use )
  • on damaged or broken skin
Adverse Reaction (ADVERSE REACTION)

May stain or damage some fabrics of surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray KIDS Broad Spectrum SPF 50.

**Oxybenzone & Octinoxate free

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

©2021 Ahold Delhaize Licensing Sarl

Quality guaranteed or your money back.

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15% 

Octisalate 5%

Octocrylene 8%

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 120ºF.
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 Conrol Center right away


Advanced Ingredient Data


Raw Label Data

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