Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f6457973-3718-44cd-a764-de0b089d4eee
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (67 mg) Titanium Dioxide (46 mg)
Inactive Ingredients
Water Dimethicone Isododecane Alcohol Butylene Glycol Perlite Nylon-12 Isopropyl Lauroyl Sarcosinate Diisopropyl Sebacate Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Disteardimonium Hectorite Bis-peg/ppg-14/14 Dimethicone Magnesium Sulfate, Unspecified Form Aluminum Hydroxide Phenoxyethanol Disodium Stearoyl Glutamate Powdered Cellulose Dipentaerythrityl Tetrahydroxystearate/tetraisostearate Ascorbyl Glucoside Calcium Aluminum Borosilicate Tocopherol Silicon Dioxide .alpha.-hexylcinnamaldehyde Benzyl Salicylate Butylated Hydroxytoluene Linalool, (+/-)- Isomethyl-.alpha.-ionone Benzyl Alcohol .beta.-citronellol, (r)- Ferric Oxide Red Bismuth Oxychloride Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

Octinoxate 6.7% Titanium dioxide 4.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 6.7% Titanium dioxide 4.6%

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 beore using
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscren 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 4.6%

Flammable Until Dry.

Do not use near fire, flames or heat.

Inactive Ingredients

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, HDI/trimethylol hexyllactone crosspolymer,  disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone,  magnesium sulfate,  aluminum hydroxide,  phenoxyethanol,  disodium stearoyl glutamate,  hydrogen dimethicone,  cellulose,  dipentaerythrityl tetrahydroxystearate/tetraisostearate,  ascorbyl glucoside,  silica silylate,  fragrance,  calcium aluminum borosilicate,  tocopherol,  silica,  hexyl cinnamal,  benzyl salicylate, BHT,  linalool,  alpha-isomethyl ionone,  benzyl alcohol,  citronellol; may contain:  titanium dioxide,  iron oxides,  bismuth oxychloride,  mica

Questions Or Comments?

1-800-322-2036

Monday - Friday

(10 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

For sunscreen use:

  • shake well beore using
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscren 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 4.6%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flames or heat.

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, nylon-12, isopropyl lauroyl sarcosinate, diisopropyl sebacate, HDI/trimethylol hexyllactone crosspolymer,  disteardimonium hectorite, BIS -PEG/PPG-14/14 dimethicone,  magnesium sulfate,  aluminum hydroxide,  phenoxyethanol,  disodium stearoyl glutamate,  hydrogen dimethicone,  cellulose,  dipentaerythrityl tetrahydroxystearate/tetraisostearate,  ascorbyl glucoside,  silica silylate,  fragrance,  calcium aluminum borosilicate,  tocopherol,  silica,  hexyl cinnamal,  benzyl salicylate, BHT,  linalool,  alpha-isomethyl ionone,  benzyl alcohol,  citronellol; may contain:  titanium dioxide,  iron oxides,  bismuth oxychloride,  mica

Questions Or Comments? (Questions or comments?)

1-800-322-2036

Monday - Friday

(10 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.


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