Drug Facts

Drug Facts
SPL v15
SPL
SPL Set ID c0f7ae46-7161-4d48-9386-007bfafecfd5
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (50 mg) Zinc Cation (150 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Isohexadecane Isononyl Isononanoate Dicaprylyl Ether Peg-30 Dipolyhydroxystearate Polyglyceryl-4 Isostearate Dicaprylyl Carbonate Triethylhexanoin Silicon Dioxide Citric Acid Monohydrate Phenoxyethanol Sodium Chloride Caprylyl Glycol Diethylhexyl Syringylidenemalonate Triethoxycaprylylsilane Aluminum Hydroxide Stearic Acid Aluminum Stearate Chlorphenesin Disteardimonium Hectorite Aluminum Oxide Tocopherol P-anisic Acid Capryloyl Salicylic Acid Xanthan Gum Edetate Disodium Propylene Carbonate Medium-chain Triglycerides Senna Alata Leaf Maltodextrin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-15
Description

Titanium dioxide 5% Zinc Oxide 15%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 5% Zinc Oxide 15%

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 cuased by the sun
Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

  • apply generously 15 minutes before sun exposure
  • reapply:
  •    after 80 minutes of swimming or sweating
  •    immediately after towel 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

Drug Facts

Titanium dioxide 5%

Zinc Oxide 15%

Other Information
  • protect the product is this container from excessive heat and direct sun
Inactive Ingredients

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethylhexanoin, silica, poly C10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, diethylhexyl syringylidenemalonate, triethoxycaprylylsilane, aluminum hydroxide, stearic acid, aluminum stearate, chlorphnesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, tocopherol, p-ansic acid, capryloyl salicylic acid, xanthan gum, disodium EDTA, propylene carbonate, caprylic/capric triglyceride, cassia alata leaf extract, maltodextrin

Questions Or Comments?

1-888-LRP-LABO 1-888-577-5226

Monday-Friday (9 a.m.-5 p.m. EST)

When Using This Product

keep out of eyes. Rinse with water to remove.

Keep Out of Reach of Children.

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

Stop Use and Ask A Doctor If 

rash occurs

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 cuased by the sun
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

Directions

For sunscreen use:

  • apply generously 15 minutes before sun exposure
  • reapply:
  •    after 80 minutes of swimming or sweating
  •    immediately after towel 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

Drug Facts

Titanium dioxide 5%

Zinc Oxide 15%

Other Information (Other information)
  • protect the product is this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

water, C12-15 alkyl benzoate, isohexadecane, isononyl isononanoate, dicaprylyl ether, PEG-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, dicaprylyl carbonate, ethylene/acrylic acid copolymer, triethylhexanoin, silica, poly C10-30 alkyl acrylate, citric acid, phenoxyethanol, sodium chloride, caprylyl glycol, diethylhexyl syringylidenemalonate, triethoxycaprylylsilane, aluminum hydroxide, stearic acid, aluminum stearate, chlorphnesin, disteardimonium hectorite, alumina, polyhydroxystearic acid, tocopherol, p-ansic acid, capryloyl salicylic acid, xanthan gum, disodium EDTA, propylene carbonate, caprylic/capric triglyceride, cassia alata leaf extract, maltodextrin

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO 1-888-577-5226

Monday-Friday (9 a.m.-5 p.m. EST)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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.

Stop Use and Ask A Doctor If  (Stop use and ask a doctor if )

rash occurs

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.102279 · Updated: 2026-03-14T23:02:18.218337