drug facts

drug facts
SPL v4
SPL
SPL Set ID 9302bccb-636d-45f1-8919-9b98c2e68567
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 (50 mg) octisalate (72 mg) octocrylene
Inactive Ingredients
water glycerin silicon dioxide dimethicone peg-100 stearate glyceryl monostearate ammonium polyacryloyldimethyl taurate (55000 mpa.s) stearic acid phenoxyethanol palmitic acid polyethylene glycol 1600 ascorbyl glucoside dicaprylyl carbonate steareth-100 propanediol phenylethyl resorcinol capryloyl salicylic acid caprylyl glycol xanthan gum dimethicone/vinyl dimethicone crosspolymer (soft particle) edetate disodium tocopherol hyaluronate sodium sodium hydroxide myristic acid pineapple papain

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-08-01
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7.2%

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:

  • 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. – 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, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, stearic acid, phenoxyethanol, palmitic acid, PEG-32, ascorbyl glucoside, dicaprylyl carbonate, steareth-100, propanediol, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, sodium hydroxide, myristic acid, ananas sativus (pineapple) fruit extract, papain

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7.2%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredient

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Questions Or Comments?

1-800-370-1925

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:

  • 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. – 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, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, ammonium polyacryloyldimethyl taurate, stearic acid, phenoxyethanol, palmitic acid, PEG-32, ascorbyl glucoside, dicaprylyl carbonate, steareth-100, propanediol, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, fragrance, disodium EDTA, tocopherol, sodium hyaluronate, sodium hydroxide, myristic acid, ananas sativus (pineapple) fruit extract, papain

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Questions Or Comments? (Questions or comments?)

1-800-370-1925

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: 2026-02-15T12:02:38.040727 · Updated: 2026-03-14T23:02:18.218337