Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 74ea4031-bb23-4028-ae32-78213646f66c
Route
TOPICAL
Published
Effective Date 2023-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Octisalate (70 mg) Octocrylene
Inactive Ingredients
Water Glycerin Dimethicone Glyceryl Monostearate Hydroxypropyl Tetrahydropyrantriol Silicon Dioxide Peg-100 Stearate Propylene Glycol Candelilla Wax Phenoxyethanol Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Stearic Acid Dicaprylyl Carbonate Cetyl Alcohol Palmitic Acid Capryloyl Salicylic Acid Caprylyl Glycol Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Edetate Disodium Tocopherol Hyaluronate Sodium Adenosine Linalool, (+/-)- Sodium Hydroxide Jasminum Officinale Flower .beta.-citronellol, (r)- Geraniol Citral Benzyl Alcohol Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-01
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:

     ● 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

Active Ingredient

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Other Information

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

Inactive Ingredients

water, glycerin, dimethicone, glyceryl stearate, hydroxypropyl tetrahydropyrantriol, silica, PEG-100 stearate, propylene glycol, euphorbia cerifera (candelilla) wax, phenoxyethanol, ammonium polyacryloyldimethyl taurate, stearic acid, dicaprylyl carbonate, cetyl alcohol, palmitic acid, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, adenosine, linalool, sodium hydroxide, jasminum officinale (jasmine) flower extract, citronellol, geraniol, citral, benzyl alcohol, citric acid

Questions Or Comments?

Call toll free 1-800-946-4453

Monday - Friday (9 a.m. to 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

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

Active Ingredient (Active ingredient)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, dimethicone, glyceryl stearate, hydroxypropyl tetrahydropyrantriol, silica, PEG-100 stearate, propylene glycol, euphorbia cerifera (candelilla) wax, phenoxyethanol, ammonium polyacryloyldimethyl taurate, stearic acid, dicaprylyl carbonate, cetyl alcohol, palmitic acid, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, adenosine, linalool, sodium hydroxide, jasminum officinale (jasmine) flower extract, citronellol, geraniol, citral, benzyl alcohol, citric acid

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

Monday - Friday (9 a.m. to 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: 2026-02-15T12:02:37.285732 · Updated: 2026-03-14T23:02:16.200124