Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 8a2fd46c-5767-4621-8e69-dd291f9fe5b1
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (130 mg) Octisalate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Water Dimethicone Glycerin Cyclomethicone 6 Polymethylsilsesquioxane (4.5 Microns) Niacinamide Silicon Dioxide Caprylyl Trisiloxane Medium-chain Triglycerides Caprylyl Glycol Chlorphenesin Diethylhexyl Syringylidenemalonate Glyceryl Distearate Inulin Lauryl Carbamate P-anisic Acid Panthenol Peg-100 Stearate Peg-8 Laurate Phenoxyethanol Potassium Cetyl Phosphate Sodium Dodecylbenzenesulfonate Hyaluronate Sodium Tocopherol Trolamine Trisodium Ethylenediamine Disuccinate Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01
Description

Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 10%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 10%

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 generously 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

Active Ingredient

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 10%

Other Information

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

Inactive Ingredients

water, dimethicone, glycerin, styrene/acrylates copolymer, poly c10-30 alkyl acrylate, polymethylsilsesquioxane, acrylates/dimethicone copolymer, niacinamide, silica, caprylyl methicone, acrylates/c10-30 alkyl acrylate crosspolymer, caprylic/capric triglyceride, caprylyl glycol, chlorphenesin, diethylhexyl syringylidenemalonate, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, panthenol, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, sodium dodecylbenzenesulfonate, sodium hyaluronate, tocopherol, triethanolamine, trisodium ethylenediamine disuccinate, xanthan gum

Questions Or Comments?

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 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 generously 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

Active Ingredient (Active ingredient)

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 10%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, dimethicone, glycerin, styrene/acrylates copolymer, poly c10-30 alkyl acrylate, polymethylsilsesquioxane, acrylates/dimethicone copolymer, niacinamide, silica, caprylyl methicone, acrylates/c10-30 alkyl acrylate crosspolymer, caprylic/capric triglyceride, caprylyl glycol, chlorphenesin, diethylhexyl syringylidenemalonate, glyceryl stearate, inulin lauryl carbamate, p-anisic acid, panthenol, PEG-100 stearate, PEG-8 laurate, phenoxyethanol, potassium cetyl phosphate, sodium dodecylbenzenesulfonate, sodium hyaluronate, tocopherol, triethanolamine, trisodium ethylenediamine disuccinate, xanthan gum

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 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: 2026-02-15T12:02:38.090893 · Updated: 2026-03-14T23:02:18.218337