Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID e924bfd5-d64d-4918-b57b-7d4da28bd013
Route
TOPICAL
Published
Effective Date 2023-10-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (28 mg) Homosalate (95 mg) Octisalate (48 mg) Octocrylene (70 mg)
Inactive Ingredients
Water Glycerin Dipropylene Glycol Panthenol Ethylhexyl Methoxycrylene Isopropyl Palmitate Silicon Dioxide Niacinamide Cetearyl Olivate Cetostearyl Alcohol Glyceryl Monostearate Potassium Cetyl Phosphate Sorbitan Olivate .alpha.-tocopherol Acetate Caprylyl Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Palmitic Acid Ethylhexylglycerin Stearic Acid Leontopodium Nivale Subsp. Alpinum Flowering Top 1,2-hexanediol Rice Germ Propanediol Sodium Hydroxide Adenosine Citric Acid Monohydrate Myristic Acid Tocopherol Buddleja Davidii Leaf Thymus Vulgaris Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01
Description

Avobenzone 2.8% .................Sunscreen Homosalate 9.5% .....................Sunscreen Octisalate 4.8% ..................Sunscreen Octocrylene 7% .................Sunscreen

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.8% .................Sunscreen Homosalate 9.5% .....................Sunscreen Octisalate 4.8% ..................Sunscreen Octocrylene 7% .................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
Active Ingredients

Avobenzone 2.8% .................Sunscreen

Homosalate 9.5% .....................Sunscreen

Octisalate 4.8% ..................Sunscreen

Octocrylene 7% .................Sunscreen

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, Oryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract

Otc Purpose Section

Sunscreen

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.

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

NEW

DERMATOLOGIST RECOMMENDED

FOR SENSITIVE SKIN



Cetaphil ®



SUN

35

Hydrating Face

 Sunscreen

 Broad Spectrum SPF 35

Formulated for sensitive skin

Oil-free, lightweight

sunscreen hydrates and 

protects against

sun damage

Antioxidant Vitamins B3 and E

plus Vitamin B5

Skin Cancer Foundation logo

3 FL OZ (88 mL)





Distributed by:

Galderma Laboratories, L.P.

Dallas, Texas 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com

P57554-0





















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
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
Active Ingredients

Avobenzone 2.8% .................Sunscreen

Homosalate 9.5% .....................Sunscreen

Octisalate 4.8% ..................Sunscreen

Octocrylene 7% .................Sunscreen

Inactive Ingredients

Water, Glycerin, Dipropylene Glycol, Panthenol (Vitamin B5), Ethylhexyl Methoxycrylene, lsopropyl Palmitate, Silica, Niacinamide, Cetearyl Olivate, Cetearyl Alcohol, Glyceryl Stearate, Potassium Cetyl Phosphate, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E Acetate), Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Palmitic Acid, Ethylhexylglycerin, Stearic Acid, Leontopodium Alpinum Flower/Leaf Extract, 1,2-Hexanediol, Oryza Saliva (Rice) Lees Extract, Propanediol, Sodium Hydroxide, Adenosine, Citric Acid, Myristic Acid, Tocopherol (Vitamin E), Buddleja Davidii (Summer Lilac) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract

Otc Purpose Section (OTC - PURPOSE SECTION)

Sunscreen

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.

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)

NEW

DERMATOLOGIST RECOMMENDED

FOR SENSITIVE SKIN



Cetaphil ®



SUN

35

Hydrating Face

 Sunscreen

 Broad Spectrum SPF 35

Formulated for sensitive skin

Oil-free, lightweight

sunscreen hydrates and 

protects against

sun damage

Antioxidant Vitamins B3 and E

plus Vitamin B5

Skin Cancer Foundation logo

3 FL OZ (88 mL)





Distributed by:

Galderma Laboratories, L.P.

Dallas, Texas 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com

P57554-0





















Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:11.539822 · Updated: 2026-03-14T23:01:36.166619