Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 23235897-c1fc-423f-99a2-e2ad282ee744
Route
TOPICAL
Published
Effective Date 2024-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Octisalate (72 mg) Octocrylene
Inactive Ingredients
Water Glycerin Silicon Dioxide Propanediol Dimethicone Niacinamide Alcohol Titanium Dioxide Glyceryl 1-stearate Peg-100 Stearate Mica Tranexamic Acid Stearic Acid Palmitic Acid Ammonium Polyacryloyldimethyl Taurate Squalane Hydroxyacetophenone Dicaprylyl Carbonate Steareth-100 Caprylyl Glycol Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Citric Acid Monohydrate Butylene Glycol Magnesium Potassium Aluminosilicate Fluoride Trisodium Ethylenediamine Disuccinate Tocopherol Hyaluronate Sodium Myristic Acid Stannic Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01
Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7.2%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7.2%

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:

  • shake well before use

●  apply liberally 15 minutes before sun exposure

●  reapply:

    ●  after 80 minutes of swimming or sweating

    ●  immediately after towel drying

    ●  at least every 2 hours

● 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
  • store at 68 – 77° F (20 – 25°C)
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Inactive Ingredients

water, glycerin, silica, propanediol, dimethicone, niacinamide, alcohol denat., titanium dioxide, glyceryl stearate, PEG-100 stearate, mica, tranexamic acid, stearic acid, palmitic acid,ammonium polyacryloyldimethyl taurate, squalene, hydroxyacetophenone, dicaprylyl carbonate, steareth-100, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, citric acid, butylene glycol, synthetic fluorphlogopite, trisodium ethylenediamine disuccinate, tocopherol, sodium hyaluronate, myristic acid, tin oxide, mineral salts

Questions Or Comments?

Call toll free 1-877-378-4249

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:

  • shake well before use

●  apply liberally 15 minutes before sun exposure

●  reapply:

    ●  after 80 minutes of swimming or sweating

    ●  immediately after towel drying

    ●  at least every 2 hours

● 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
  • store at 68 – 77° F (20 – 25°C)
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Inactive Ingredients (Inactive ingredients)

water, glycerin, silica, propanediol, dimethicone, niacinamide, alcohol denat., titanium dioxide, glyceryl stearate, PEG-100 stearate, mica, tranexamic acid, stearic acid, palmitic acid,ammonium polyacryloyldimethyl taurate, squalene, hydroxyacetophenone, dicaprylyl carbonate, steareth-100, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, citric acid, butylene glycol, synthetic fluorphlogopite, trisodium ethylenediamine disuccinate, tocopherol, sodium hyaluronate, myristic acid, tin oxide, mineral salts

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-378-4249

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: 2026-02-15T12:03:17.272495 · Updated: 2026-03-14T23:03:17.077951