Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8bdd63f7-2f67-4280-9484-d6c8e80ad9b9
Route
TOPICAL
Published
Effective Date 2023-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (170 mg) Zinc Oxide (80 mg)
Inactive Ingredients
Isohexadecane Water Dimethicone Triethylhexanoin C15-19 Alkane Silicon Dioxide Alkyl (c12-15) Benzoate Caprylyl Trisiloxane Butyloctyl Salicylate Ferric Oxide Red Aluminum Stearate Dicaprylyl Carbonate Dicaprylyl Ether Talc Dimethicone/peg-10/15 Crosspolymer Aluminum Oxide Polyhydroxystearic Acid (2300 Mw) Peg-9 Polydimethylsiloxyethyl Dimethicone Pentylene Glycol 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Aluminum Hydroxide Stearic Acid Phenoxyethanol Magnesium Sulfate, Unspecified Form Caprylyl Glycol Triethoxycaprylylsilane Disteardimonium Hectorite Diethylhexyl Syringylidenemalonate Tocopherol Disodium Stearoyl Glutamate Propylene Carbonate Senna Alata Leaf Maltodextrin Dipropylene Glycol Sodium Citrate Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-15

Description

Titanium dioxide 17% Zinc oxide 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium dioxide 17% Zinc oxide 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
  • shake well before use
  • apply generously 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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
Do Not Use

on damaged or broken skin

Other Information

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

Active Ingredients

Titanium dioxide 17%

Zinc oxide 8%

Inactive Ingredients

iron oxides , isohexadecane, dimethicone, triethylhexanoin, c15-19 alkane, silica, c12-15 alkyl benzoate, caprylyl methicone, butyloctyl salicylate, aluminum stearate, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, alumina, polyhydroxystearic acid water, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol ● acrylates/dimethicone copolymer, aluminum hydroxide, stearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, disodium stearoyl glutamate, triethoxycaprylylsilane, disteardimonium hectorite, diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, dipropylene glycol, sodium citrate, caprylic/capric triglyceride

Questions Or Comments?

1-888-LRP LABO 1-888-577-5226

Monday - Friday (9 a.m. - 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
  • shake well before use
  • apply generously 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • 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
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

Active Ingredients (Active ingredients)

Titanium dioxide 17%

Zinc oxide 8%

Inactive Ingredients (Inactive ingredients)

iron oxides , isohexadecane, dimethicone, triethylhexanoin, c15-19 alkane, silica, c12-15 alkyl benzoate, caprylyl methicone, butyloctyl salicylate, aluminum stearate, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, alumina, polyhydroxystearic acid water, PEG-9 polydimethylsiloxyethyl dimethicone, pentylene glycol ● acrylates/dimethicone copolymer, aluminum hydroxide, stearic acid, phenoxyethanol, magnesium sulfate, caprylyl glycol, disodium stearoyl glutamate, triethoxycaprylylsilane, disteardimonium hectorite, diethylhexyl syringylidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, dipropylene glycol, sodium citrate, caprylic/capric triglyceride

Questions Or Comments? (Questions or comments?)

1-888-LRP LABO 1-888-577-5226

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.

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

All Sections (JSON)