Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 2a44a019-0cc0-439b-aaa5-37582ec5492e
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octocrylene (40 mg) Ethylhexyl Salicylate (50 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 Phenoxyethanol Aluminum Hydroxide Snail Secretion Filtrate Adenosine Butylene Glycol Sodium Hyaluronate Glycerin Steareth-20 Chlorhexidine Digluconate N-hydroxysuccinimide Sodium Citrate Potassium Sorbate Palmitoyl Tripeptide-1 Chrysin Palmitoyl Tetrapeptide-7 Citric Acid Biotin Ferric Oxide Red Ferric Oxide Yellow

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

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

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 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, aluminum hydroxide, snail secretion filtrate, adenosine, butylene glycol, sodium hyaluronate, glycerin, 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

Questions Or Comments?

Call 800-620-3950

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

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 diisostearate/polyhydroxystearate/sebacate, magnesium sulfate, phenoxyethanol, aluminum hydroxide, snail secretion filtrate, adenosine, butylene glycol, sodium hyaluronate, glycerin, 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

Questions Or Comments? (Questions or comments?)

Call 800-620-3950

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

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