Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6925c546-056e-4be8-b4e9-55da0b6b62b3
Route
TOPICAL
Published
Effective Date 2024-06-28
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 Niacinamide Alcohol Dimethicone Isohexadecane Aluminum Starch Octenylsuccinate Isopropyl Isostearate Boron Nitride Ammonium Acryloyldimethyltaurate/vp Copolymer Docosanol Phenoxyethanol Squalane Cetyl Alcohol Glyceryl Monostearate Peg-100 Stearate Capryloyl Salicylic Acid Cetostearyl Alcohol Trisodium Ethylenediamine Disuccinate Hyaluronate Sodium Tocopherol Titanium Dioxide Carbomer Homopolymer, Unspecified Type Cetearyl Glucoside Sodium Hydroxide Stannic Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-13
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 sunscren 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

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, niacinamide, alcohol denat., dimethicone, isohexadecane, aluminum starch octenylsuccinate, isopropyl isostearate, boron nitride, ammonium acryloyldimethyltaurate/VP copolymer, behenyl alcohol, phenoxyethanol, squalane, cetyl alcohol, glyceryl stearate, PEG-100 stearate, capryloyl salicylic acid, cetearyl alcohol, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, sodium hyaluronate, tocopherol, titanium dioxide, carbomer, cetearyl glucoside, sodium hydroxide, tin oxide

Questions Or Comments?

Call toll free 1-800-946-4453

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 sunscren 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)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, niacinamide, alcohol denat., dimethicone, isohexadecane, aluminum starch octenylsuccinate, isopropyl isostearate, boron nitride, ammonium acryloyldimethyltaurate/VP copolymer, behenyl alcohol, phenoxyethanol, squalane, cetyl alcohol, glyceryl stearate, PEG-100 stearate, capryloyl salicylic acid, cetearyl alcohol, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, sodium hyaluronate, tocopherol, titanium dioxide, carbomer, cetearyl glucoside, sodium hydroxide, tin oxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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: 2026-02-15T12:03:13.065115 · Updated: 2026-03-14T23:03:10.704753