345918e3-95f8-404c-e063-6394a90a3fca

SPL v2
SPL
SPL Set ID 345918e3-95f8-404c-e063-6394a90a3fca
Route
topical
Published
Effective Date 2025-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (11 g)
Inactive Ingredients
magnesium sulfate polyhydroxystearic acid (2300 mw) peg-9 polydimethylsiloxyethyl dimethicone phenoxyethanol disteardimonium hectorite propylene carbonate isohexadecane phenethyl benzoate peg-8 laurate benzoic acid ci 77499 undecane triethoxycaprylylsilane senna alata leaf alumina isododecane styrene/acrylamide copolymer (mw 500000) triethylhexanoin dimethicone 200 maltodextrin ci 77491 disodium stearoyl glutamate tridecane dicaprylyl ether tocopherol diethylhexyl syringylidenemalonate water butyloctyl salicylate caprylic/capric triglyceride ci 77492 aluminum stearate pentylene glycol c12-15 alkyl benzoate nylon-12 dimethicone/peg-10/15 crosspolymer dicaprylyl carbonate caprylyl methicone silicon dioxide ethylhexylglycerin stearic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-03
Description

Titanium Dioxide 11%

Medication Information

Warnings and Precautions

For external use only.

do not use on damaged or broken skin.

When using this product avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation developss and lasts.

Active Ingredient

Titanium Dioxide 11%

Indications and Usage

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.

Dosage and Administration

For sunscreen use: shake well before use, apply liberally 15 minutes before sun exposure and as needed, reapply:

after 40 minutes of swimming or sweating, immediately after towel drying, and 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.

Description

Titanium Dioxide 11%

Section 50565-1

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

Section 51727-6

C12-15 alkyl bonzoate, water, isododecane, diemthicone, styrene/acrylates copolymer, undecane, triethylhexanoin, butyloctyl salicylate, nylon-12, isohexadecane, caprylyl methicone, phenethyl benzoate, aluminum stearate, dimethicone/PEG-10/15 crosspolymer, dicaprylyl carbonate, tridecane, disteardimonium hectorite, dicaprylyl ether, pentyle glycol, silica, propylene carbonate, phenoxyethanol, ethylhexylglycerin, stearic acid, PEG-8 laurate, PEG-9 polydimethylsiloxyethyl dimethicone, magnesium sulfate, benzoic acid, disodium stearoyl glutamate, tocopherol, diethylhexyl syringylidenemalonate, caprylic/capric triglyceride, iron oxides (CI 77492, CI 77499, CI 77491), triethoxycaprylysilane, maltodextrin, cassia alata leaf extract, polyhydroxystearic acid, alumina

Section 51945-4

Section 55105-1

Sunscreen

Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

do not use on damaged or broken skin.

When using this product avoid contact with eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation developss and lasts.

Active Ingredient (55106-9)

Titanium Dioxide 11%

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

For sunscreen use: shake well before use, apply liberally 15 minutes before sun exposure and as needed, reapply:

after 40 minutes of swimming or sweating, immediately after towel drying, and 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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

C12-15 alkyl bonzoate, water, isododecane, diemthicone, styrene/acrylates copolymer, undecane, triethylhexanoin, butyloctyl salicylate, nylon-12, isohexadecane, caprylyl methicone, phenethyl benzoate, aluminum stearate, dimethicone/PEG-10/15 crosspolymer, dicaprylyl carbonate, tridecane, disteardimonium hectorite, dicaprylyl ether, pentyle glycol, silica, propylene carbonate, phenoxyethanol, ethylhexylglycerin, stearic acid, PEG-8 laurate, PEG-9 polydimethylsiloxyethyl dimethicone, magnesium sulfate, benzoic acid, disodium stearoyl glutamate, tocopherol, diethylhexyl syringylidenemalonate, caprylic/capric triglyceride, iron oxides (CI 77492, CI 77499, CI 77491), triethoxycaprylysilane, maltodextrin, cassia alata leaf extract, polyhydroxystearic acid, alumina

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:00.749217 · Updated: 2026-03-14T23:13:32.363247