Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID e7bef1da-ea35-4306-b043-73d566a7e6bb
Route
TOPICAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Ethylhexyl Salicylate (70 mg) Octocrylene
Inactive Ingredients
Water Glycerin Niacinamide Dimethicone Aluminum Starch Octenylsuccinate Isopropyl Isostearate Isohexadecane Squalane Boron Nitride Acetyl Hexapeptide-8 Capryloyl Salicylic Acid Sodium Hyaluronate Sodium Hydroxide Trisodium Ethylenediamine Disuccinate Ascorbyl Glucoside Retinyl Palmitate Tocopherol Cetyl Alcohol Ammonium Acryloyldimethyltaurate/vp Copolymer Behenyl Alcohol Cetearyl Alcohol Cetearyl Glucoside Glyceryl Stearate Peg-100 Stearate Polysorbate 80 Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Sorbitan Oleate Benzyl Alcohol Benzyl Salicylate Coumarin Linalool Phenoxyethanol Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-01
Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%

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:

    o limit time in the sun, especially from 10 a.m. - 2 p.m.

    o 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

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, niacinamide, dimethicone, alcohol denat., aluminum starch octenylsuccinate, isopropyl isostearate, isohexadecane, squalane, boron nitride, acetyl hexapeptide-8, capryloyl salicylic acid, sodium hyaluronate, sodium hydroxide, trisodium ethylenediamine disuccinate, ascorbyl glucoside, retinyl palmitate, tocopherol, cetyl alcohol, ammonium acryloyldimethyltaurate/VP copolymer, behenyl alcohol, carbomer, cetearyl alcohol, cetearyl glucoside, glyceryl stearate, PEG-100 stearate, polysorbate 80, sodium acrylate/sodium acryloyldimethyl taurate copolymer, sorbitan oleate, benzyl alcohol, benzyl salicylate, coumarin, linalool, phenoxyethanol, sodium benzoate, fragrance

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:

    o limit time in the sun, especially from 10 a.m. - 2 p.m.

    o 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)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, niacinamide, dimethicone, alcohol denat., aluminum starch octenylsuccinate, isopropyl isostearate, isohexadecane, squalane, boron nitride, acetyl hexapeptide-8, capryloyl salicylic acid, sodium hyaluronate, sodium hydroxide, trisodium ethylenediamine disuccinate, ascorbyl glucoside, retinyl palmitate, tocopherol, cetyl alcohol, ammonium acryloyldimethyltaurate/VP copolymer, behenyl alcohol, carbomer, cetearyl alcohol, cetearyl glucoside, glyceryl stearate, PEG-100 stearate, polysorbate 80, sodium acrylate/sodium acryloyldimethyl taurate copolymer, sorbitan oleate, benzyl alcohol, benzyl salicylate, coumarin, linalool, phenoxyethanol, sodium benzoate, fragrance

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: 2026-02-15T12:06:02.325090 · Updated: 2026-03-14T23:08:30.723878