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

Description

Avobenzone 3% Homosalate 12% 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 12% 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

*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.

Other Information

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

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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

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)

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

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

*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.

Other Information (Other information)

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

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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)

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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