Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 87496037-36ca-4c5f-973f-46626cf4096e
Route
TOPICAL
Published
Effective Date 2024-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (110 mg)
Inactive Ingredients
Water Dimethicone Isododecane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-01

Description

Titanium dioxide 11%

Purpose

Sunscreen


Medication Information

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

Purpose

Sunscreen

Description

Titanium dioxide 11%

Section 51945-4

Warnings

For external use only

Directions

For sunscreen use:

● shake well before use

● apply liberally 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 asunscreen 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 11%

Other Information

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

Inactive Ingredients

water, dimethicone, isododecane, c12-15 alkyl benzoate, talc, alcohol denat., undecane, propanediol, styrene/acrylates copolymer, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, tridecane, dimethicone/PEG-10/15 crosspolymer, PEG-9 polydimethylsiloxyethyl dimethicone, aluminum hydroxide, aluminum stearate, phenoxyethanol, stearic acid, lycium barbarum fruit extract, sodium chloride, caprylyl glycol, PEG-8 laurate, alumina, polyhydroxystearic acid, disteardimonium hectorite, propylene carbonate, tocopherol, benzoic acid, 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

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

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:

  ● 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 asunscreen 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 11%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, c12-15 alkyl benzoate, talc, alcohol denat., undecane, propanediol, styrene/acrylates copolymer, butyloctyl salicylate, phenethyl benzoate, triethylhexanoin, isohexadecane, tridecane, dimethicone/PEG-10/15 crosspolymer, PEG-9 polydimethylsiloxyethyl dimethicone, aluminum hydroxide, aluminum stearate, phenoxyethanol, stearic acid, lycium barbarum fruit extract, sodium chloride, caprylyl glycol, PEG-8 laurate, alumina, polyhydroxystearic acid, disteardimonium hectorite, propylene carbonate, tocopherol, benzoic acid, 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

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