drug facts

drug facts
SPL v1
SPL
SPL Set ID 6925c546-056e-4be8-b4e9-55da0b6b62b3
Route
topical
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (50 mg) octisalate (70 mg) octocrylene
Inactive Ingredients
water glycerin niacinamide alcohol dimethicone isohexadecane aluminum starch octenylsuccinate isopropyl isostearate boron nitride ammonium acryloyldimethyltaurate/vp copolymer docosanol phenoxyethanol squalane cetyl alcohol glyceryl monostearate peg-100 stearate capryloyl salicylic acid cetostearyl alcohol trisodium ethylenediamine disuccinate hyaluronate sodium tocopherol titanium dioxide carbomer homopolymer, unspecified type cetearyl glucoside sodium hydroxide stannic oxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-13
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% 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:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscren 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, niacinamide, alcohol denat., dimethicone, isohexadecane, aluminum starch octenylsuccinate, isopropyl isostearate, boron nitride, ammonium acryloyldimethyltaurate/VP copolymer, behenyl alcohol, phenoxyethanol, squalane, cetyl alcohol, glyceryl stearate, PEG-100 stearate, capryloyl salicylic acid, cetearyl alcohol, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, sodium hyaluronate, tocopherol, titanium dioxide, carbomer, cetearyl glucoside, sodium hydroxide, tin oxide

Description

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

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Questions Or Comments?

Call toll free 1-800-946-4453

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 sunscren 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, niacinamide, alcohol denat., dimethicone, isohexadecane, aluminum starch octenylsuccinate, isopropyl isostearate, boron nitride, ammonium acryloyldimethyltaurate/VP copolymer, behenyl alcohol, phenoxyethanol, squalane, cetyl alcohol, glyceryl stearate, PEG-100 stearate, capryloyl salicylic acid, cetearyl alcohol, dimethicone/vinyl dimethicone crosspolymer, trisodium ethylenediamine disuccinate, synthetic fluorphlogopite, sodium hyaluronate, tocopherol, titanium dioxide, carbomer, cetearyl glucoside, sodium hydroxide, tin oxide

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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: 2026-02-15T12:03:13.065115 · Updated: 2026-03-14T23:03:10.704753