Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a1cab79d-0151-49ee-86dc-c2739842e62e
Route
TOPICAL
Published
Effective Date 2024-12-23
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 C12-15 Alkyl Benzoate Isohexadecane Isononyl Isononanoate Dicaprylyl Ether Peg-30 Dipolyhydroxystearate Triethylhexanoin Polyglyceryl-4 Isostearate Dicaprylyl Carbonate Stearic Acid Ceramide Np Ceramide Ap Carbomer Niacinamide Glycine Soja (soybean) Oil Cetearyl Alcohol Triethoxycaprylylsilane Behentrimonium Methosulfate Triethyl Citrate Sodium Chloride Sodium Hyaluronate Sodium Lauroyl Lactylate Cholesterol Aluminum Stearate Alumina Aluminum Hydroxide Phenoxyethanol Iron Oxides 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 (2300 Mw) Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-15

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 eadrly skin aging

  caused by the sun

Section 51945-4

Warnings

For external use only

Questions

Questions or comments?

Toll-free number 1-888-768-2915

Directions

For sunscreen use:

· apply literally 15 minutes before sun exposure

· reaply 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 the 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 (soybean) oil, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, triethyl citrate, sodium chloride, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, 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

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 eadrly skin aging

  caused by the sun

Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Questions

Questions or comments?

Toll-free number 1-888-768-2915

Directions

For sunscreen use:

· apply literally 15 minutes before sun exposure

· reaply 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 the 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 (soybean) oil, cetearyl alcohol, triethoxycaprylylsilane, behentrimonium methosulfate, triethyl citrate, sodium chloride, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, aluminum stearate, alumina, aluminum hydroxide, iron oxides, 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

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

All Sections (JSON)