Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 66a91768-6012-485a-b569-a293ea6d4880
Route
TOPICAL
Published
Effective Date 2024-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (67 mg) Titanium Dioxide (11 mg)
Inactive Ingredients
Water Dimethicone Isododecane Alcohol Trimethylsiloxysilicate (m/q 0.6-0.8) Butylene Glycol Magnesium Potassium Aluminosilicate Fluoride Peg-10 Dimethicone (600 Cst) Perlite Disteardimonium Hectorite Nylon-12 Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Isopropyl Lauroyl Sarcosinate Diisopropyl Sebacate Bis-peg/ppg-14/14 Dimethicone Magnesium Sulfate, Unspecified Form Phenoxyethanol Disodium Stearoyl Glutamate Dipentaerythrityl Tetrahydroxystearate/tetraisostearate Glycerin Tocopherol Medium-chain Triglycerides Hydrogen Dimethicone (13 Cst) Silicon Dioxide Butylated Hydroxytoluene Jasminum Officinale Flower Benzyl Alcohol Hyaluronate Sodium Phenylethyl Alcohol Linalool, (+/-)- Carrageenan Lemon Peel Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-07-25 Until 2027-03-04

Description

Octinoxate 6.7% Titanium dioxide 1.1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 1.1%

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 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

Octinoxate 6.7%

Titanium dioxide 1.1%

Flammable Until Dry.

Avoid fire, flame and heat during application.

Inactive Ingredients

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, synthetic fluorphlogopite, perlite, disteardimonium hectorite, nylon-12, HDI/trimethylol hexyllactone crosspolymer, aluminum hydroxide, isopropyl lauroyl sarcosinate, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone,magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, silica silylate, glycerin, tocopherol, caprylic/capric triglyceride, hydrogen dimethicone, silica, BHT, jasminum officinale (jasmine) flower extract, benzyl alcohol, sodium hyaluronate, phenethyl alcohol, linalool, sodium carrageenan, citrus limon (lemon) peel extract, jania rubens extract, fragrance; may contain: iron oxides, titanium dioxide

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 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)

Octinoxate 6.7%

Titanium dioxide 1.1%

Flammable Until Dry. (Flammable until dry.)

Avoid fire, flame and heat during application.

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, synthetic fluorphlogopite, perlite, disteardimonium hectorite, nylon-12, HDI/trimethylol hexyllactone crosspolymer, aluminum hydroxide, isopropyl lauroyl sarcosinate, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone,magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, silica silylate, glycerin, tocopherol, caprylic/capric triglyceride, hydrogen dimethicone, silica, BHT, jasminum officinale (jasmine) flower extract, benzyl alcohol, sodium hyaluronate, phenethyl alcohol, linalool, sodium carrageenan, citrus limon (lemon) peel extract, jania rubens extract, fragrance; may contain: iron oxides, titanium dioxide

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.


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Raw Label Data

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