care one 769.000/769aa

care one 769.000/769aa
SPL v5
SPL
SPL Set ID 79dff6ec-d958-4bba-999b-da4aa67519f5
Route
topical
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (50 mg) octocrylene (100 mg) avobenzone (30 mg) homosalate
Inactive Ingredients
water ethylhexyl palmitate sorbitol polyamide-8 (4500 mw) benzyl alcohol tocopherol medium-chain triglycerides trolamine carbomer interpolymer type a (allyl sucrose crosslinked) chlorphenesin sodium ascorbyl phosphate oleth-3 edetate disodium anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-01-12

Purpose

Sunscreen

Description

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


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
  • 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, especiallyu 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

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Description

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

Principal Display Panel

Care One

Compare to Coppertone Ultra Guard Sunscreen Lotion SPF 30*

Sunscreen

Lotion

SPF 30 UVA/UVB Protection

BROAD SPECTRUM SPF 30

  • Water resistant (80 minutes)
  • Enriched with moisturizers
  • Hypoallergenic

REEF FRIENDLY**

8 FL OZ (236 mL)

Do Not Use
  • on damaged or broken skin
Adverse Reaction

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-849-9949

(C) 2019 S&S Brands, LLC

Quality guaranteed your your money back.

May stain or damage some fabrics or surfaces.

*This product is not manufacured or distribued by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 30.

**Oxybenzone & Octinoxate free

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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
  • 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, especiallyu 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 (Inactive ingredients)

water, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, olethe-3, disodium EDTA

Principal Display Panel (principal display panel)

Care One

Compare to Coppertone Ultra Guard Sunscreen Lotion SPF 30*

Sunscreen

Lotion

SPF 30 UVA/UVB Protection

BROAD SPECTRUM SPF 30

  • Water resistant (80 minutes)
  • Enriched with moisturizers
  • Hypoallergenic

REEF FRIENDLY**

8 FL OZ (236 mL)

Do Not Use (Do not use)
  • on damaged or broken skin
Adverse Reaction (ADVERSE REACTION)

Distributed by Foodhold USA, LLC

Landover, MD 20785

1-877-849-9949

(C) 2019 S&S Brands, LLC

Quality guaranteed your your money back.

May stain or damage some fabrics or surfaces.

*This product is not manufacured or distribued by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 30.

**Oxybenzone & Octinoxate free

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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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