drug facts

drug facts
SPL v7
SPL
SPL Set ID eb43177e-389d-4572-8521-ee4d0a2dad3a
Route
topical
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (150 mg)
Inactive Ingredients
water isododecane dimethicone alkyl (c12-15) benzoate undecane caprylyl trisiloxane nylon-12 butyloctyl salicylate phenethyl benzoate dicaprylyl carbonate silicon dioxide triethylhexanoin isohexadecane tridecane dicaprylyl ether talc aluminum hydroxide stearic acid pentylene glycol peg-9 polydimethylsiloxyethyl dimethicone ferric oxide red aluminum stearate peg-8 laurate phenoxyethanol magnesium sulfate, unspecified form caprylyl glycol aluminum oxide disteardimonium hectorite tocopherol propylene carbonate benzoic acid disodium stearoyl glutamate polyethylene glycol 450

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2015-12-01

Purpose

Sunscreen

Description

Titanium dioxide 15%


Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

Directions

For sunscreen use:

  • shake well before use
  • apply liberally 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 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

Other Information

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

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, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, aluminum stearate, PEG-8 laurate, phenoxyethanol, magnesium sulfate, caprylyl glycol, alumina, polyhydroxystearic acid, disteardimonium hectorite, tocopherol, propylene carbonate, benzoic acid, disodium stearoyl glutamate, PEG-9

Description

Titanium dioxide 15%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Titanium dioxide 15%

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

Warnings

For external use only

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
Purpose

Sunscreen

Directions

For sunscreen use:

  • shake well before use
  • apply liberally 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 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

Other Information (Other information)

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

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, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethicone, iron oxides, aluminum stearate, PEG-8 laurate, phenoxyethanol, magnesium sulfate, caprylyl glycol, alumina, polyhydroxystearic acid, disteardimonium hectorite, tocopherol, propylene carbonate, benzoic acid, disodium stearoyl glutamate, PEG-9

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Titanium dioxide 15%

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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