Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID f296e5ef-728a-4d57-8d65-7d88b1f90f88
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 (100 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate Propylene Glycol Diisopropyl Sebacate Glycerin Alcohol Dimethicone Potassium Cetyl Phosphate Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Medium-chain Triglycerides Caprylyl Glycol Diethylhexyl Syringylidenemalonate Edetate Disodium Glyceryl Monostearate Hypromellose, Unspecified Isopropyl Lauroyl Sarcosinate Myristic Acid Palmitic Acid Peg-100 Stearate Peg-8 Laurate Pentylene Glycol Phenoxyethanol Sodium Chloride Stearic Acid Tert-butyl Alcohol Tocopherol Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-01
Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% 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 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 10%

Octisalate 5%

Octocrylene 7%

Other Information

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

Inactive Ingredients

water, C12-15 alkyl benzoate, propylene glycol, diisopropyl sebacate, styrene/acrylates copolymer, glycerin, alcohol denat., dimethicone, potassium cetyl phosphate, acrylates copolymer, ammonium polyacryloyldimethyl taurate, caprylic/capric triglyceride, caprylyl glycol, diethylhexyl syringylidenemalonate, disodium EDTA, glyceryl stearate, hydroxypropyl methylcellulose, isopropyl lauroyl sarcosinate, myristic acid, palmitic acid, PEG-100 stearate, PEG-8 laurate, pentylene glycol, phenoxyethanol, sodium chloride, stearic acid, t-butyl alcohol, tocopherol, triethanolamine

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 10%

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, C12-15 alkyl benzoate, propylene glycol, diisopropyl sebacate, styrene/acrylates copolymer, glycerin, alcohol denat., dimethicone, potassium cetyl phosphate, acrylates copolymer, ammonium polyacryloyldimethyl taurate, caprylic/capric triglyceride, caprylyl glycol, diethylhexyl syringylidenemalonate, disodium EDTA, glyceryl stearate, hydroxypropyl methylcellulose, isopropyl lauroyl sarcosinate, myristic acid, palmitic acid, PEG-100 stearate, PEG-8 laurate, pentylene glycol, phenoxyethanol, sodium chloride, stearic acid, t-butyl alcohol, tocopherol, triethanolamine

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: 2026-02-15T12:02:38.066891 · Updated: 2026-03-14T23:02:18.218337