Drug Facts

Drug Facts
SPL v21
SPL
SPL Set ID 6d3c5fc5-c818-46c4-8db3-cffcdcd56e06
Route
TOPICAL
Published
Effective Date 2023-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (110 mg)
Inactive Ingredients
Water Isododecane Alkyl (c12-15) Benzoate Dimethicone Undecane Triethylhexanoin Isohexadecane Styrene/acrylamide Copolymer (mw 500000) Nylon-12 Caprylyl Trisiloxane Butyloctyl Salicylate Phenethyl Benzoate Silicon Dioxide Tridecane Dicaprylyl Carbonate Dicaprylyl Ether Talc Aluminum Stearate Pentylene Glycol Tocopherol Phenoxyethanol Stearic Acid Diethylhexyl Syringylidenemalonate Peg-9 Polydimethylsiloxyethyl Dimethicone Magnesium Sulfate, Unspecified Form Peg-8 Laurate Polyhydroxystearic Acid (2300 Mw) Maltodextrin Benzoic Acid Propylene Glycol Propylene Carbonate Caprylyl Glycol Disteardimonium Hectorite Aluminum Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-01

Description

Titanium dioxide 11%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 11%

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 generously 15 minutes before sun exposure

- reapply:

- after 40 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 meausures 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 11%

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

water, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, C9-15 fluoroalcohol phosphate, tocopherol, phenoxyethanol, stearic acid, diethylhexyl syringylidenemalonate, PEG-9 polydimethylsiloxyethyl dimethcone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, maltodextrin, benzoic acid, iron oxides, propylene glycol, propylene carbonate, caprylyl glycol, disteardimonim hectorite, cassia alata leaf extract, alumina, aluminum hydroxide

Questions Or Comments?

1-888-577-5226   1-888-LRP LABO

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 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 generously 15 minutes before sun exposure

- reapply:

- after 40 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 meausures 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 11%

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

water, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, C9-15 fluoroalcohol phosphate, tocopherol, phenoxyethanol, stearic acid, diethylhexyl syringylidenemalonate, PEG-9 polydimethylsiloxyethyl dimethcone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, maltodextrin, benzoic acid, iron oxides, propylene glycol, propylene carbonate, caprylyl glycol, disteardimonim hectorite, cassia alata leaf extract, alumina, aluminum hydroxide

Questions Or Comments? (Questions or comments?)

1-888-577-5226   1-888-LRP LABO

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

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