Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID cd69df67-5231-4a75-a9fb-a8669806a892
Route
TOPICAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (60 mg) Octisalate (50 mg) Octocrylene (70 mg) Zinc Oxide
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Isohexadecane Isononyl Isononanoate Dicaprylyl Ether Peg-30 Dipolyhydroxystearate Triethylhexanoin Polyglyceryl-4 Isostearate Dicaprylyl Carbonate Acrylic Acid/ethylene Copolymer (600 Mpa.s) Trolamine Silicon Dioxide Stearic Acid Ceramide Np Ceramide Ap Ceramide 1 Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Niacinamide Cetostearyl Alcohol Triethoxycaprylylsilane Behentrimonium Methosulfate Sodium Chloride Salicylic Acid Hyaluronate Sodium Sodium Lauroyl Lactylate Cholesterol Aluminum Stearate Aluminum Oxide Aluminum Hydroxide Ferric Oxide Red Phenoxyethanol P-anisic Acid Chlorphenesin Tocopherol Edetate Disodium Disodium Stearoyl Glutamate Propylene Carbonate Citric Acid Monohydrate Caprylyl Glycol Capryloyl Salicylic Acid Medium-chain Triglycerides Diethylhexyl Syringylidenemalonate Disteardimonium Hectorite Xanthan Gum Phytosphingosine Phytosphingosine Hydrochloride Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-10

Description

Homosalate 6% Octisalate 5% Octocrylene 5% Zinc oxide 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 6% Octisalate 5% Octocrylene 5% Zinc oxide 7%

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

Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply:

  • after 80 minutes or swimming or sweating
  • immediately after towl 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, especially 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

Other Information

protect the product in this container from excessive heat and direct sun

Active Ingredients

Homosalate 6%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients



water, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethanolamine, silica, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, sodium chloride, salicylic acid, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, phenoxyethanol, p-anisic acid, chlorphenesin, tocoferol, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, ethylhexylglycerin

Questions Or Comments?

Toll-free number 1-888-768-2915

www.CeraVe.com

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

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

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

● apply liberally 15 minutes before sun exposure

● reapply:

  • after 80 minutes or swimming or sweating
  • immediately after towl 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, especially 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

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Active Ingredients (Active ingredients)

Homosalate 6%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients (Inactive ingredients)



water, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethanolamine, silica, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, sodium chloride, salicylic acid, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, phenoxyethanol, p-anisic acid, chlorphenesin, tocoferol, disodium EDTA, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, ethylhexylglycerin

Questions Or Comments? (Questions or comments?)

Toll-free number 1-888-768-2915

www.CeraVe.com

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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