Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 8598d56b-adcd-48e8-b6fc-77bc934009c7
Route
TOPICAL
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (10 mg) Titanium Dioxide (29 mg)
Inactive Ingredients
Water Isododecane Dimethicone Cyclomethicone 6 Glycerin Butylene Glycol Ascorbyl Glucoside Pentylene Glycol Disteardimonium Hectorite Sodium Chloride Polyglyceryl-4 Isostearate Hexyl Laurate Caprylyl Glycol Isostearyl Neopentanoate Phenoxyethanol Aluminum Oxide Disodium Stearoyl Glutamate Phenylethyl Resorcinol Tocopherol Panthenol Hydroxypropyl Tetrahydropyrantriol Aluminum Hydroxide Propylene Glycol Stannic Oxide Butylated Hydroxytoluene Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Ferric Oxide Red Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01
Description

Octinoxate 1% Titanium dioxide 2.9%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octinoxate 1% Titanium dioxide 2.9%

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 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 our 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 1%

Titanium dioxide 2.9%

Flammable Until Dry.

Do not use near fire, flames or heat.

Inactive Ingredients

water, isododecane, dimethicone, cyclohexasiloxane, glycerin, PEG-10 dimethicone, methyl methacrylate crosspolymer, butylene glycol, ascorbyl glucoside, pentylene glycol, cetyl PEG/PPG-10/1 dimethicone, disteardimonium hectorite, synthetic fluorphlogopite, sodium chloride, polyglyceryl-4 isostearate, hexyl laurate, caprylyl glycol, isostearyl neopentanoate, phenoxyethanol, alumina, disodium stearoyl glutamate, phenylethyl resorcinol, tocopherol, panthenol, hydroxypropyl tetrahydropyrantriol, aluminum hydroxide, propylene glycol, tin oxide, BHT, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides, mica

When Using This Product

keep out of eyes. Rinse with water to remove.

Questions Or Comments? 

1-800-322-2036

Monday - Friday

(10 a.m. - 5 p.m. EST)

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 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 our 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 1%

Titanium dioxide 2.9%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flames or heat.

Inactive Ingredients (Inactive ingredients)

water, isododecane, dimethicone, cyclohexasiloxane, glycerin, PEG-10 dimethicone, methyl methacrylate crosspolymer, butylene glycol, ascorbyl glucoside, pentylene glycol, cetyl PEG/PPG-10/1 dimethicone, disteardimonium hectorite, synthetic fluorphlogopite, sodium chloride, polyglyceryl-4 isostearate, hexyl laurate, caprylyl glycol, isostearyl neopentanoate, phenoxyethanol, alumina, disodium stearoyl glutamate, phenylethyl resorcinol, tocopherol, panthenol, hydroxypropyl tetrahydropyrantriol, aluminum hydroxide, propylene glycol, tin oxide, BHT, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides, mica

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Questions Or Comments?  (Questions or comments? )

1-800-322-2036

Monday - Friday

(10 a.m. - 5 p.m. EST)

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.068818 · Updated: 2026-03-14T23:03:10.704753