Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID eb43177e-389d-4572-8521-ee4d0a2dad3a
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (150 mg)
Inactive Ingredients
Water Isododecane Dimethicone Alkyl (c12-15) Benzoate Undecane Caprylyl Trisiloxane Nylon-12 Butyloctyl Salicylate Phenethyl Benzoate Dicaprylyl Carbonate Silicon Dioxide Triethylhexanoin Isohexadecane Tridecane Dicaprylyl Ether Talc Aluminum Hydroxide Stearic Acid Pentylene Glycol Peg-9 Polydimethylsiloxyethyl Dimethicone Ferric Oxide Red Aluminum Stearate Peg-8 Laurate Phenoxyethanol Magnesium Sulfate, Unspecified Form Caprylyl Glycol Aluminum Oxide Disteardimonium Hectorite Tocopherol Propylene Carbonate Benzoic Acid Disodium Stearoyl Glutamate Polyethylene Glycol 450

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-01
Description

Titanium dioxide 15%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 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 caused by the sun
Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

  • shake well before 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

Active Ingredient

Titanium dioxide 15%

Other Information

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

Inactive Ingredients

water, isododecane, dimethicone, C12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, aluminum stearate, PEG-8 laurate, phenoxyethanol, magnesium sulfate, caprylyl glycol, alumina, polyhydroxystearic acid, disteardimonium hectorite, tocopherol, propylene carbonate, benzoic acid, disodium stearoyl glutamate, PEG-9

Questions Or Comments?

Call toll free 1-800-946-4453

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:

  • shake well before 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

Active Ingredient (Active ingredient)

Titanium dioxide 15%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, isododecane, dimethicone, C12-15 alkyl benzoate, undecane, styrene/acrylates copolymer, caprylyl methicone, nylon-12, butyloctyl salicylate, phenethyl benzoate, dicaprylyl carbonate, silica, triethylhexanoin, isohexadecane, tridecane, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum hydroxide, stearic acid, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, aluminum stearate, PEG-8 laurate, phenoxyethanol, magnesium sulfate, caprylyl glycol, alumina, polyhydroxystearic acid, disteardimonium hectorite, tocopherol, propylene carbonate, benzoic acid, disodium stearoyl glutamate, PEG-9

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:37.336244 · Updated: 2026-03-14T23:02:16.200124