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

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 12% Octisalate 5%

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
Warnings

For external use only

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
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.

Other Information
  • Protect the product from excessive heat and direct sun
Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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

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)

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

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

Warnings

For external use only

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
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.

Other Information (Other information)
  • Protect the product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 12%

Octisalate 5%

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)

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

All Sections (JSON)