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
Purpose

Sunscreen

Description

Homosalate 10% Octisalate 5% Octocrylene 4%

Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

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

Description

Homosalate 10% Octisalate 5% Octocrylene 4%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Flammable Until Dry.

Do not use near fire, flames or heat.

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

Warnings

For external use only

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
Purpose

Sunscreen

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
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
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

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Homosalate 10%

Octisalate 5%

Octocrylene 4%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flames or heat.

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