care one d40.000/d40aa

care one d40.000/d40aa
SPL v4
SPL
SPL Set ID 5d213553-f946-460c-88c3-fa41f12c3b7c
Route
topical
Published
Effective Date 2023-12-27
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
.alpha.-amylcinnamaldehyde water diethylhexyl 2,6-naphthalate butyloctyl salicylate styrene/acrylamide copolymer (500000 mw) aluminum starch octenylsuccinate glycerin polyester-7 silicon dioxide chlorphenesin benzyl alcohol arachidyl alcohol carbomer copolymer type b (allyl pentaerythritol crosslinked) neopentyl glycol diheptanoate docosanol tocopherol yellow wax arachidyl glucoside potassium hydroxide glyceryl monostearate peg-100 stearate edetate disodium anhydrous sodium ascorbyl phosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-27 Until 2024-01-06

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%


Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply:
  • after 80 minutes of swimming or sweating
  • mmediately 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 from excessive heat and direct sun
Inactive Ingredients

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, amyl cinnamal

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Principal Display Panel

CAREone

Compare to Coppertone Sunscreen Lotion Sport*

SPORT

Sunscnreen Lotion

SPF 50

UVA/UVB SUNSCREEN

Broad Spectrum SPF 50

  • Water resistant (80 min)
  • Formulated without Oxybenzone & Octinoxate

NET 1.5 FL OZ (44 mL)

Disclaimer

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Sunscreen Lotion Sport 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, NC 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
Stop Use and Ask A Doctor If
  • rash occurs
Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions
  • apply liberally 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • reapply:
  • after 80 minutes of swimming or sweating
  • mmediately 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 from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, glycerin, polyester-7, silica, chlorphenesin, benzyl alcohol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, neopentyl glycol diheptanoate, behenyl alcohol, tocopherol, beeswax, arachidyl glucoside, potassium hydroxide, glyceryl stearate, PEG-100 stearate, disodium EDTA, sodium ascorbyl phosphate, fragrance, amyl cinnamal

Principal Display Panel (Principal display panel)

CAREone

Compare to Coppertone Sunscreen Lotion Sport*

SPORT

Sunscnreen Lotion

SPF 50

UVA/UVB SUNSCREEN

Broad Spectrum SPF 50

  • Water resistant (80 min)
  • Formulated without Oxybenzone & Octinoxate

NET 1.5 FL OZ (44 mL)

Disclaimer

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Sunscreen Lotion Sport 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, NC 28147

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

Quality guaranteed or your money back.

Active Ingredients (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
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 Control Center right away.


Advanced Ingredient Data


Raw Label Data

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