Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 097fc15e-ea17-47b2-9581-19c5e11592f6
Route
TOPICAL
Published
Effective Date 2024-12-30
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 Cyclomethicone 5 Alcohol Silicon Dioxide Dicaprylyl Ether Styrene/acrylamide Copolymer (500000 Mw) Peg-30 Dipolyhydroxystearate Dimethicone Cyclomethicone 6 Polymethylsilsesquioxane (4.5 Microns) Glycerin Nylon-12 Butylene Glycol Caprylyl Glycol Citric Acid Monohydrate Edetate Disodium Disteardimonium Hectorite Isostearyl Alcohol Lauryl Peg/ppg-18/18 Methicone P-anisic Acid Peg-8 Laurate Phenoxyethanol Potassium Sorbate Propylene Carbonate Sodium Benzoate Sodium Chloride Sodium Dodecylbenzenesulfonate Tocopherol Wine Grape

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-01 Until 2020-05-01
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 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

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry.

Keep away from flames and heat.

Inactive Ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, glycerin, nylon-12, butylene glycol, caprylyl glycol, citric acid, dicaprylyl carbonate, disodium EDTA, disteardimonium hectorite, fragrance, isostearyl alcohol, lauryl PEG/PPG-18/18 methicone, p-anisic acid, PEG-8 laurate, phenoxyethanol, poly c10-30 alkyl acrylate, potassium sorbate, propylene carbonate, sodium benzoate, sodium chloride, sodium dodecylbenzenesulfonate, tocopherol,

vitis vinifera (grape) fruit extract

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:

●  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

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry. (Flammable until dry.)

Keep away from flames and heat.

Inactive Ingredients (Inactive ingredients)

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, glycerin, nylon-12, butylene glycol, caprylyl glycol, citric acid, dicaprylyl carbonate, disodium EDTA, disteardimonium hectorite, fragrance, isostearyl alcohol, lauryl PEG/PPG-18/18 methicone, p-anisic acid, PEG-8 laurate, phenoxyethanol, poly c10-30 alkyl acrylate, potassium sorbate, propylene carbonate, sodium benzoate, sodium chloride, sodium dodecylbenzenesulfonate, tocopherol,

vitis vinifera (grape) fruit extract

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: 2026-02-15T12:05:07.614654 · Updated: 2026-03-14T23:06:30.937806