Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 9302bccb-636d-45f1-8919-9b98c2e68567
Route
TOPICAL
Published
Effective Date 2023-12-31
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 Dimethicone Peg-100 Stearate Glyceryl Monostearate Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Stearic Acid Phenoxyethanol Palmitic Acid Polyethylene Glycol 1600 Ascorbyl Glucoside Dicaprylyl Carbonate Steareth-100 Propanediol Phenylethyl Resorcinol Capryloyl Salicylic Acid Caprylyl Glycol Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Edetate Disodium Tocopherol Hyaluronate Sodium Sodium Hydroxide Myristic Acid Pineapple Papain

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-01
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:

  • 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 7.2%

Other Information

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

Inactive Ingredients

water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, stearic acid, phenoxyethanol, palmitic acid, PEG-32, ascorbyl glucoside, dicaprylyl carbonate, steareth-100, propanediol, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, sodium hydroxide, myristic acid, ananas sativus (pineapple) fruit extract, papain

Questions Or Comments?

1-800-370-1925

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 7.2%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, stearic acid, phenoxyethanol, palmitic acid, PEG-32, ascorbyl glucoside, dicaprylyl carbonate, steareth-100, propanediol, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, sodium hydroxide, myristic acid, ananas sativus (pineapple) fruit extract, papain

Questions Or Comments? (Questions or comments?)

1-800-370-1925

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: 2026-02-15T12:02:38.040727 · Updated: 2026-03-14T23:02:18.218337