Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5b4e25ad-cd72-4960-9259-fc710bfd59da
Route
TOPICAL
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (95 mg) Octocrylene (48 mg) Octisalate (28 mg) Avobenzone
Inactive Ingredients
Water Glycerin Dipropylene Glycol Panthenol Butyloctyl Salicylate Silicon Dioxide Yellow Wax Niacinamide Cetearyl Olivate Sodium Stearoyl Lactylate Glyceryl Monostearate Potassium Cetyl Phosphate Sorbitan Olivate .alpha.-tocopherol Acetate Caprylyl Glycol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Palmitic Acid Ethylhexylglycerin Leontopodium Nivale Subsp. Alpinum Root Stearic Acid 1,2-hexanediol Rice Germ Sodium Hydroxide Propanediol Adenosine Citric Acid Monohydrate Hydrolyzed Soy Protein (enzymatic; 2000 Mw) Buddleja Davidii Whole Thyme

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-12

Description

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

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 9.5% .................Sunscreen Octocrylene 9.5% .........… Sunscreen Octisalate 4.8% ...............…   Sunscreen Avobenzone 2.8% ................. 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, GLYCERIN, DIPROPYLENE GLYCOL, PANTHENOL, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

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

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

Octocrylene 9.5% .........… Sunscreen

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

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

Keep Out of Reach of Children.

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

Principal Display Panel 1.7 Oz Carton

Cetaphil®



DAY

CREAM



HEALTHY RENEW

30

BROAD SPECTRUM

SPF 30 (UVA/UVB)

SUNSCREEN



Retinol Alternative



All Skin Types

Hydrates, and visibly

smooths fine lines 



Purified Peptides,

Vitamins B3 & B5



Dermatologist Recommended Sensitive Skin Icon



NET WT 1.7 OZ (48 g)



Distributed by:

Galderma Laboratories, L.P., Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com  

P57224-2


























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, GLYCERIN, DIPROPYLENE GLYCOL, PANTHENOL, BUTYLOCTYL SALICYLATE, SILICA, BEESWAX, NIACINAMIDE, CETEARYL OLIVATE, SODIUM STEAROYL LACTYLATE, GLYCERYL STEARATE, POTASSIUM CETYL PHOSPHATE, SORBITAN OLIVATE, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, PALMITIC ACID, ETHYLHEXYLGLYCERIN, LEONTOPODIUM ALPINUM EXTRACT, STEARIC ACID, 1,2-HEXANEDIOL, ORYZA SATIVA (RICE) LEES EXTRACT, SODIUM HYDROXIDE, PROPANEDIOL, ADENOSINE, CITRIC ACID, HYDROLYZED SOY FLOUR, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) EXTRACT

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)

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

Octocrylene 9.5% .........… Sunscreen

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

Avobenzone 2.8% ................. 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 1.7 Oz Carton (Principal Display Panel - 1.7 OZ Carton)

Cetaphil®



DAY

CREAM



HEALTHY RENEW

30

BROAD SPECTRUM

SPF 30 (UVA/UVB)

SUNSCREEN



Retinol Alternative



All Skin Types

Hydrates, and visibly

smooths fine lines 



Purified Peptides,

Vitamins B3 & B5



Dermatologist Recommended Sensitive Skin Icon



NET WT 1.7 OZ (48 g)



Distributed by:

Galderma Laboratories, L.P., Dallas, TX 75201 USA

All trademarks are the property of their respective owners.

cetaphil.com  

P57224-2


























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