Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID acb887bc-7e46-4257-9fe3-a2cade6c4f38
Route
TOPICAL
Published
Effective Date 2023-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (148 mg)
Inactive Ingredients
Water Isododecane Dimethicone Alkyl (c12-15) Benzoate Undecane Styrene/acrylamide Copolymer (500000 Mw) Caprylyl Trisiloxane Nylon-12 Butyloctyl Salicylate Phenethyl Benzoate Dicaprylyl Carbonate Silicon Dioxide Triethylhexanoin Isohexadecane Tridecane Dicaprylyl Ether Talc Dimethicone/peg-10/15 Crosspolymer Aluminum Hydroxide Stearic Acid Peg-9 Polydimethylsiloxyethyl Dimethicone Pentylene Glycol Aluminum Oxide Aluminum Stearate Benzoic Acid Benzyl Benzoate Caprylyl Glycol Ferric Oxide Red Dipropylene Glycol Disodium Stearoyl Glutamate Disteardimonium Hectorite Magnesium Sulfate, Unspecified Form Peg-8 Laurate Phenoxyethanol Polyhydroxystearic Acid (2300 Mw) Propylene Carbonate Sodium Citrate Sodium Dodecylbenzenesulfonate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-12-01

Description

Titanium dioxide 14.8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 14.8%

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:

    ●  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 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

Other Information
  • protect the product in this container from excessive heat and direct sun
  • store at 68 – 77° F (20 – 25°C)
Active Ingredients

Titanium dioxide 14.8%

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, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

Questions Or Comments?

Call toll free 1-877-378-4249

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

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:

    ●  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 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

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
  • store at 68 – 77° F (20 – 25°C)
Active Ingredients (Active ingredients)

Titanium dioxide 14.8%

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, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol, alumina, aluminum stearate, benzoic acid, benzyl benzoate, caprylyl glycol, iron oxides, dipropylene glycol, disodium stearoyl glutamate, disteardimonium hectorite, helianthus annuus seed oil/sunflower seed oil, magnesium sulfate, PEG-8 laurate, phenoxyethanol, polyhydroxystearic acid, propylene carbonate, sodium citrate, sodium dodecylbenzenesulfonate, tocopherol

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-378-4249

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

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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