Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 2bdc6c73-d3e7-4a23-89dd-e4ffe44c034b
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (83 mg) Octisalate (45 mg) Octocrylene (56 mg)
Inactive Ingredients
Water Glycerin Caprylyl Trisiloxane Dimethicone Butyloctyl Salicylate Niacinamide Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Propanediol Dimethicone/peg-10/15 Crosspolymer Magnesium Potassium Aluminosilicate Fluoride Butylene Glycol Trimethylsiloxysilicate (m/q 0.6-0.8) Phenoxyethanol Sodium Chloride Disteardimonium Hectorite Disodium Stearoyl Glutamate Chlorphenesin Trisodium Ethylenediamine Disuccinate Limonene, (+)- Maltodextrin Aluminum Hydroxide Adenosine Dipropylene Glycol Ethohexadiol Hyaluronate Sodium Citral Sodium Citrate Linalool, (+/-)- Green Tea Leaf Tocopherol Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-18
Description

Homosalate 8.3% Octisalate 4.5% Octocrylene 5.6%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 8.3% Octisalate 4.5% Octocrylene 5.6%

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 8.3%

Octisalate 4.5%

Octocrylene 5.6%

Inactive Ingredients

water, glycerin, caprylyl methicone, dimethicone, butyloctyl salicylate, niacinamide, cetyl PEG/PPG-10/1 dimethicone, propanediol, dimethicone/PEG-10/15 crosspolymer, synthetic fluorphlogopite, butylene glycol, trimethylsiloxysilicate, phenoxyethanol, sodium chloride, disteardimonium hectorite, disodium stearoyl glutamate, fragrance, chlorphenesin, snail secretion filtrate, silica silylate, trisodium ethylenediamine disuccinate, limonene, maltodextrin, aluminum hydroxide, adenosine, dipropylene glycol, ethyl hexanediol, sodium hyaluronate, citral, sodium citrate, linalool, camellia sinensis leaf extract, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Questions Or Comments?

Call 800-620-3956

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 8.3%

Octisalate 4.5%

Octocrylene 5.6%

Inactive Ingredients (Inactive ingredients)

water, glycerin, caprylyl methicone, dimethicone, butyloctyl salicylate, niacinamide, cetyl PEG/PPG-10/1 dimethicone, propanediol, dimethicone/PEG-10/15 crosspolymer, synthetic fluorphlogopite, butylene glycol, trimethylsiloxysilicate, phenoxyethanol, sodium chloride, disteardimonium hectorite, disodium stearoyl glutamate, fragrance, chlorphenesin, snail secretion filtrate, silica silylate, trisodium ethylenediamine disuccinate, limonene, maltodextrin, aluminum hydroxide, adenosine, dipropylene glycol, ethyl hexanediol, sodium hyaluronate, citral, sodium citrate, linalool, camellia sinensis leaf extract, tocopherol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate; may contain: titanium dioxide, iron oxides

Questions Or Comments? (Questions or comments?)

Call 800-620-3956

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: 2026-02-15T12:02:37.270249 · Updated: 2026-03-14T23:02:16.200124