Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 9f8786cc-bef6-4449-8f31-dfc08de77734
Route
TOPICAL
Published
Effective Date 2025-03-25
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 Propanediol Alcohol Magnesium Potassium Aluminosilicate Fluoride Niacinamide Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Caffeine Tocopherol Peg-30 Dipolyhydroxystearate Disodium Stearoyl Glutamate Disteardimonium Hectorite Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Magnesium Sulfate, Unspecified Form Phenoxyethanol Scutellaria Baicalensis Root Aluminum Hydroxide Butylene Glycol Adenosine Hyaluronate Sodium Glycerin Ethohexadiol Steareth-20 Chlorhexidine Gluconate N-hydroxysuccinimide Sodium Citrate Potassium Sorbate Palmitoyl Tripeptide-1 Chrysin Palmitoyl Tetrapeptide-7 Citric Acid Monohydrate Biotin Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-01
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 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

Questions?

Call 800-620-3956

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, flame, or heat.

Inactive Ingredients

water, dimethicone, propanediol, alcohol denat., synthetic fluorphlogopite, niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, caffeine, tocopherol, PEG-30 dipolyhydroxystearate, disodium stearoyl glutamate, disteardimonium hectorite, polyglyceryl-4 iisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, scutellaria baicalensis root extract, aluminum hydroxide, butylene glycol, adenosine, sodium hyaluronate, snail secretion filtrate, glycerin, ethyl hexanediol, steareth-20, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, potassium sorbate, palmitoyl tripeptide-1, chrysin, palmitoyl tetrapeptide-7, citric acid, biotin; 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:

● 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

Questions?

Call 800-620-3956

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, flame, or heat.

Inactive Ingredients (Inactive ingredients)

water, dimethicone, propanediol, alcohol denat., synthetic fluorphlogopite, niacinamide, vinyl dimethicone/methicone silsesquioxane crosspolymer, caffeine, tocopherol, PEG-30 dipolyhydroxystearate, disodium stearoyl glutamate, disteardimonium hectorite, polyglyceryl-4 iisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, scutellaria baicalensis root extract, aluminum hydroxide, butylene glycol, adenosine, sodium hyaluronate, snail secretion filtrate, glycerin, ethyl hexanediol, steareth-20, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, potassium sorbate, palmitoyl tripeptide-1, chrysin, palmitoyl tetrapeptide-7, citric acid, biotin; 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:47.586529 · Updated: 2026-03-14T23:08:06.304944