drug facts

drug facts
SPL v9
SPL
SPL Set ID 03593e3c-c98a-43af-82bc-10331e23342c
Route
topical
Published
Effective Date 2024-01-31
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 dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) alcohol silicon dioxide dicaprylyl ether styrene/acrylamide copolymer (mw 500000) peg-30 dipolyhydroxystearate dimethicone cyclomethicone 6 polymethylsilsesquioxane (11 microns) nylon-12 dicaprylyl carbonate diethylhexyl syringylidenemalonate phenoxyethanol lauryl peg/ppg-18/18 methicone sodium chloride caprylyl glycol peg-8 laurate isostearyl alcohol stearyl acrylate polymer (110000 mw) disteardimonium hectorite p-anisic acid medium-chain triglycerides edetate disodium anhydrous senna alata leaf maltodextrin propylene carbonate sodium dodecylbenzenesulfonate tocopherol

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2020-05-01 Until 2020-05-01
Purpose

Sunscreen

Description

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

Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

Directions

For sunscreen use:

  • shake well before 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
Other Information

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

Inactive Ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, diethylhexyl syringlyidenemalonate, phenoxyethanol, lauryl  PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, isostearyl alcohol, poly C10-30 alkyl acrylate, disteardimonium hectorite, p-anisic acid, caprylic/capric triglyceride, disodium EDTA, cassia alata leaf extract, maltodextrin, propylene carbonate, sodium dodecylbenzenesulfonate, tocopherol

Description

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

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry.

Avoid fire, flame and heat during application.

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

Warnings

For external use only

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

Purpose

Sunscreen

Directions

For sunscreen use:

  • shake well before 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
Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, diethylhexyl syringlyidenemalonate, phenoxyethanol, lauryl  PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, isostearyl alcohol, poly C10-30 alkyl acrylate, disteardimonium hectorite, p-anisic acid, caprylic/capric triglyceride, disodium EDTA, cassia alata leaf extract, maltodextrin, propylene carbonate, sodium dodecylbenzenesulfonate, tocopherol

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Flammable Until Dry. (Flammable until dry.)

Avoid fire, flame and heat during application.

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: 2026-02-15T12:02:45.291743 · Updated: 2026-03-14T23:02:27.804765