drug facts

drug facts
SPL v2
SPL
SPL Set ID 89b59bd7-9a91-4b99-84e7-996a8b1d499e
Route
topical
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (250 mg)
Inactive Ingredients
dimethicone alkyl (c12-15) benzoate dicaprylyl ether dimethicone/vinyl dimethicone crosspolymer (hard particle) talc triethylhexanoin isohexadecane styrene/acrylamide copolymer (500000 mw) hydrogenated jojoba oil aluminum hydroxide stearic acid aluminum stearate ferric oxide red aluminum oxide polyhydroxystearic acid (2300 mw) peg-8 laurate tocopherol water diethylhexyl syringylidenemalonate laureth-4 disodium stearoyl glutamate senna alata leaf maltodextrin medium-chain triglycerides

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2016-01-01
Purpose

Sunscreen

Description

Titanium dioxide 25%

Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions

For sunscreen use:

  • apply generously 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 of 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


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

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 lasurate, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyl glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Description

Titanium dioxide 25%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Titanium dioxide 25%

Questions Or Comments?

1-888-LRP-LABO  1-888-577-5226

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

When Using Tjhis 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

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions

For sunscreen use:

  • apply generously 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 of 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


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

dimethicone, C12-15 alkyl benzoate, dicaprylyl ether, dimethicone/vinyl dimethicone crosspolymer, talc, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, hydrogenated jojoba oil, aluminum hydroxide, stearic acid, aluminum stearate, iron oxides, silica silylate, alumina, polyhydroxystearic acid, PEG-8 lasurate, tocopherol, water, diethylhexyl syringylidenemalonate, laureth-4, disodium stearoyl glutamate, cassia alata leaf extract, maltodextrin, caprylic/capric triglyceride

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Titanium dioxide 25%

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 Tjhis Product (When using tjhis 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:38.089643 · Updated: 2026-03-14T23:02:18.218337