Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID f2e34230-7bfb-455f-8b33-6bff96fd9f0a
Route
TOPICAL
Published
Effective Date 2024-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (55 mg) Zinc Oxide (100 mg)
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) Stearic Acid Ceramide Np Ceramide Ap Ceramide 1 Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Niacinamide Glycine Soja (soybean) Oil Cetostearyl Alcohol Triethoxycaprylylsilane Behentrimonium Methosulfate Triethyl Citrate Sodium Chloride 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 Trisodium Ethylenediamine Disuccinate Diethylhexyl Syringylidenemalonate Disteardimonium Hectorite Xanthan Gum Phytosphingosine Polyhydroxystearic Acid (2300 Mw) Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-01

Description

Titanium dioxide 5.5% Zinc oxide 10%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 5.5% Zinc oxide 10%

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 at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

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

Titanium dioxide 5.5%

Zinc oxide 10%

Inactive Ingredients



water, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycine soja oil, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, triethyl citrate, sodium chloride, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, phenoxyethanol, p-anisic acid, chlorphenesin, tocopherol, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, trisodium ethylenediamine disuccinate, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, benzoic acid

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 at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

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)

Titanium dioxide 5.5%

Zinc oxide 10%

Inactive Ingredients (Inactive ingredients)



water, c12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, triethylhexanoin, polyglyceryl-4 isostearate, dicaprylyl carbonate, poly c10-30 alkyl acrylate, stearic acid, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycine soja oil, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, triethyl citrate, sodium chloride, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, phenoxyethanol, p-anisic acid, chlorphenesin, tocopherol, disodium stearoyl glutamate, propylene carbonate, citric acid, caprylyl glycol, capryloyl salicylic acid, caprylic/capric triglyceride, trisodium ethylenediamine disuccinate, diethylhexyl syringylidenemalonate, disteardimonium hectorite, xanthan gum, phytosphingosine, polyhydroxystearic acid, benzoic acid

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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