Care One 959.001 959ab

Care One 959.001 959ab
SPL v9
SPL
SPL Set ID cc4d6350-9ae8-4eb6-b670-100af59f6ada
Route
TOPICAL
Published
Effective Date 2025-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (80 mg)
Inactive Ingredients
Alcohol Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Glycerin Trolamine Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-01-18

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%

Purpose

sunscreen


Medication Information

Purpose

sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 8%

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

Warnings

For external use only

Flammable

Keep away from fire or flame.

  • after application, wait until product dries before approaching a source of heat or flame, or before smoking
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

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 Ultra Guard Broad Spectrum SPF 30.

**Oxybenzone & Octinoxate free

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

LANDOVER, MD 20785

1-877-846-9949

2021 Ahold Delhaize Licensing Sarl

Quality guraranteed or your money back

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 8%

Inactive Ingredients

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

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.
Principal Display Panel

CAREONE ®

Compare to Coppertone ®Broad Spectrum SPF 30*

SUNSCREEN 

SPRAY

SPF 30

UVA/UVB PROTECTION

Broad Spectrum SPF 30 

  • Water resistant (80 min)
  • Hypoallergenic

reef friendly**

NET WT 5.5 OZ (156 g)

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

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

Warnings (warnings)

For external use only

Flammable

Keep away from fire or flame.

  • after application, wait until product dries before approaching a source of heat or flame, or before smoking
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

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 Ultra Guard Broad Spectrum SPF 30.

**Oxybenzone & Octinoxate free

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

LANDOVER, MD 20785

1-877-846-9949

2021 Ahold Delhaize Licensing Sarl

Quality guraranteed or your money back

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%

Octocrylene 8%

Inactive Ingredients (inactive ingredients)

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

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.
Principal Display Panel (principal display panel)

CAREONE ®

Compare to Coppertone ®Broad Spectrum SPF 30*

SUNSCREEN 

SPRAY

SPF 30

UVA/UVB PROTECTION

Broad Spectrum SPF 30 

  • Water resistant (80 min)
  • Hypoallergenic

reef friendly**

NET WT 5.5 OZ (156 g)

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

All Sections (JSON)