Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 799c547c-a17a-43ee-92fc-061b5ec8a40c
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Octocrylene (40 mg)
Inactive Ingredients
Water Dimethicone Glycerin Propanediol Alcohol Niacinamide Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Peg-30 Dipolyhydroxystearate Tocopherol Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Disteardimonium Hectorite Magnesium Sulfate, Unspecified Form Phenoxyethanol Disodium Stearoyl Glutamate Aluminum Hydroxide Stearic Acid Aloe Vera Leaf Hyaluronate Sodium Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-01
Description

Homosalate 10% Octisalate 5% Octocrylene 4%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 10% Octisalate 5% Octocrylene 4%

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:

  • 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

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Flammable Until Dry.

Do not use near fire, flames or heat.

Inactive Ingredients

water, dimethicone, glycerin, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic fluorphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, disteardimonium hectorite, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, stearic acid, aloe barbadensis leaf juice powder, sodium hyaluronate; may contain: titanium dioxide, iron oxides

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:

  • 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)

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flames or heat.

Inactive Ingredients (Inactive ingredients)

water, dimethicone, glycerin, propanediol, alcohol denat., niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, synthetic fluorphlogopite, PEG-30 dipolyhydroxystearate, tocopherol, polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate, disteardimonium hectorite, magnesium sulfate, phenoxyethanol, disodium stearoyl glutamate, aluminum hydroxide, stearic acid, aloe barbadensis leaf juice powder, sodium hyaluronate; may contain: titanium dioxide, iron oxides

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.067631 · Updated: 2026-03-14T23:03:10.704753