Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 69cdf676-34f6-4864-a2a6-9f547b0b45a0
Route
TOPICAL
Published
Effective Date 2022-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (125 mg) Octisalate (50 mg) Octocrylene (80 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Butylene Glycol Isododecane Sorbitol Silicon Dioxide Styrene/acrylamide Copolymer (500000 Mw) Cetostearyl Alcohol Niacinamide Glycerin Phenoxyethanol Dimethicone Glyceryl Monostearate Peg-100 Stearate Polyoxyl 20 Cetostearyl Ether Phenylethyl Resorcinol Carbomer Homopolymer, Unspecified Type Sorbitan Monostearate Magnesium Potassium Aluminosilicate Fluoride Ethylhexylglycerin Titanium Dioxide Edetate Disodium Anhydrous Sodium Hydroxide Stannic Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01
Description

Avobenzone 3% .................Sunscreen Homosalate 12.5% .........… Sunscreen Octisalate 5% ...............…   Sunscreen Octocrylene 8% ................. Sunscreen

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% .................Sunscreen Homosalate 12.5% .........… Sunscreen Octisalate 5% ...............…   Sunscreen Octocrylene 8% ................. Sunscreen

Uses
  • 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
Warnings

For external use only



Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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
Do Not Use

▪ on damaged or broken skin

Other Information
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics
Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butylene Glycol, Isododecane, Sorbitol, Silica, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Niacinamide, Glycerin, Phenoxyethanol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Phenylethyl Resorcinol, Carbomer, Fatty Acid Ethoxylate, Sorbitan Stearate, Synthetic Fluorphlogopite, Ethylhexylglycerin, Titanium Dioxide, Disodium EDTA, Sodium Hydroxide, Tin Oxide

Otc Purpose Section

Questions Or Comments?

1-866-735-4137

When Using This Product

• keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If

• rash occurs.

Active Ingredients.....purpose

Avobenzone 3% .................Sunscreen

Homosalate 12.5% .........… Sunscreen

Octisalate 5% ...............…   Sunscreen

Octocrylene 8% ................. Sunscreen

Keep Out of Reach of Children.

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

Principal Display Panel 3 Fl Oz Carton

#1 Doctor Recommended

Sensitive Skincare Brand



Cetaphil®



HEALTHY RADIANCE

Whipped Day Cream

 Broad Spectrum SPF 30

Helps even skin tone while protecting,

hydrating and firming skin

GentleBright Complex with Niacinamide



Five Skin Sensitivity Signs



NET WT 1.7 OZ (48 g)

Distributed by:

Galderma Laboratories, L.P., Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

Cetaphil.com  

P54853-1





















Structured Label Content

Uses
  • 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

Warnings

For external use only



Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
  • 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
Do Not Use (Do not use)

▪ on damaged or broken skin

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics
Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butylene Glycol, Isododecane, Sorbitol, Silica, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Niacinamide, Glycerin, Phenoxyethanol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Phenylethyl Resorcinol, Carbomer, Fatty Acid Ethoxylate, Sorbitan Stearate, Synthetic Fluorphlogopite, Ethylhexylglycerin, Titanium Dioxide, Disodium EDTA, Sodium Hydroxide, Tin Oxide

Otc Purpose Section (OTC - PURPOSE SECTION)

Questions Or Comments? (Questions or comments?)

1-866-735-4137

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.

Active Ingredients.....purpose (Active Ingredients.....Purpose)

Avobenzone 3% .................Sunscreen

Homosalate 12.5% .........… Sunscreen

Octisalate 5% ...............…   Sunscreen

Octocrylene 8% ................. Sunscreen

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.

Principal Display Panel 3 Fl Oz Carton (Principal Display Panel - 3 FL OZ Carton)

#1 Doctor Recommended

Sensitive Skincare Brand



Cetaphil®



HEALTHY RADIANCE

Whipped Day Cream

 Broad Spectrum SPF 30

Helps even skin tone while protecting,

hydrating and firming skin

GentleBright Complex with Niacinamide



Five Skin Sensitivity Signs



NET WT 1.7 OZ (48 g)

Distributed by:

Galderma Laboratories, L.P., Fort Worth, TX 76177 USA

All trademarks are the property of their respective owners.

Cetaphil.com  

P54853-1





















Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.541388 · Updated: 2026-03-14T23:01:57.446196