care one d42.000/d42aa

care one d42.000/d42aa
SPL v4
SPL
SPL Set ID 6a455f1a-4285-44c3-820a-85a50d1bbc5b
Route
topical
Published
Effective Date 2023-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (120 mg) octisalate (50 mg)
Inactive Ingredients
alcohol diethylhexyl 2,6-naphthalate diisopropyl adipate acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (40000 mw) butyloctyl salicylate neopentyl glycol diheptanoate .alpha.-amylcinnamaldehyde hydroxycitronellal linalool, (+/-)- .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-08 Until 2024-01-06

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%


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

Other Information

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

Inactive Ingredients

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

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Principal Display Panel

CAREone ®

COMPARE TO COPPERTONE ® KIDS Broad Spectrum SPF 50*

KIDS Sunscreen Spray

SPF 50 

UVA/UVB SUNSCREEN

BROAD SPECTRUM SPF 50

water resistant (80 min)

NET WT 5.5 OZ (156 g)

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

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

May stain or damage some fabrics or surfaces

Do Not Use

on damaged or broken skin

Adverse Reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NA 28147

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

Quality Guaranteed or your money back.

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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, seek immediate medical attention or call a poison control center.

Stop Use and Ask A Doctor If 

rash occurs


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

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
Purpose

Sunscreen

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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (Principal display panel)

CAREone ®

COMPARE TO COPPERTONE ® KIDS Broad Spectrum SPF 50*

KIDS Sunscreen Spray

SPF 50 

UVA/UVB SUNSCREEN

BROAD SPECTRUM SPF 50

water resistant (80 min)

NET WT 5.5 OZ (156 g)

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

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

May stain or damage some fabrics or surfaces

Do Not Use (Do not use)

on damaged or broken skin

Adverse Reaction

DISTRIBUTED BY: ADUSA DISTRIBUTION, LLC

SALISBURY, NA 28147

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

Quality Guaranteed or your money back.

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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, seek immediate medical attention or call a poison control center.

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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