drug facts

drug facts
SPL v10
SPL
SPL Set ID 5bbd9e40-3b80-4ecb-b1d4-011090413534
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 (107 mg) octisalate (32 mg) octocrylene (60 mg) oxybenzone (39 mg)
Inactive Ingredients
water cyclomethicone 5 alcohol silicon dioxide dicaprylyl ether styrene/acrylamide copolymer (500000 mw) peg-30 dipolyhydroxystearate dimethicone cyclomethicone 6 polymethylsilsesquioxane (11 microns) nylon-12 dicaprylyl carbonate phenoxyethanol lauryl peg/ppg-18/18 methicone powdered cellulose sodium chloride caprylyl glycol peg-8 laurate disteardimonium hectorite tocopherol isostearyl alcohol p-anisic acid scutellaria baicalensis root edetate disodium dodecene poloxamer 407 propylene carbonate trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-01-01
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10.7% Octisalate 3.2% Octocrylene 6% Oxybenzone 3.9%

Medication Information

Warnings

For external use only

Flammble until dry. Do not use near fire, flame or heat.

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
  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen 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. - 2p.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, polymethylsilsequioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG- 18/18 methicone, cellulose, sodium chloride, caprylyl glycol, PEG-8 laurate, poly C10-30 alkyl acrylate, disteardimonium hectorite, tocopherol, isostearyl alcohol, p-anisic acid, scutellaria baicalensis root extract, disodium EDTA, dodecene, poloxamer 407, propylene carbonate, triethanolamine

Description

Avobenzone 3% Homosalate 10.7% Octisalate 3.2% Octocrylene 6% Oxybenzone 3.9%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 10.7%

Octisalate 3.2%

Octocrylene 6%

Oxybenzone 3.9%

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

Flammble until dry. Do not use near fire, flame or heat.

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
  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen 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. - 2p.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, polymethylsilsequioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG- 18/18 methicone, cellulose, sodium chloride, caprylyl glycol, PEG-8 laurate, poly C10-30 alkyl acrylate, disteardimonium hectorite, tocopherol, isostearyl alcohol, p-anisic acid, scutellaria baicalensis root extract, disodium EDTA, dodecene, poloxamer 407, propylene carbonate, triethanolamine

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 10.7%

Octisalate 3.2%

Octocrylene 6%

Oxybenzone 3.9%

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: 2026-02-15T12:02:38.083915 · Updated: 2026-03-14T23:02:18.218337