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

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

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

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
  • 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
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

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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

When Using This Product
  • keep out of eyes. Rinse with water to remove
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)

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
  • 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
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

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
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)

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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