drug facts

drug facts
SPL v3
SPL
SPL Set ID 02dddfc5-61e6-433b-8d6d-a17bf3fc8ed6
Route
topical
Published
Effective Date 2024-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
water alcohol glycerin dimethicone butyloctyl salicylate silicon dioxide isononyl isononanoate isopropyl myristate cetostearyl alcohol calcium aluminum borosilicate tocopherol tert-butyl alcohol ascorbyl glucoside hydrogenated soybean lecithin sodium stearoyl glutamate sodium dodecylbenzenesulfonate phenoxyethanol phenylethyl resorcinol adenosine peg-8 laurate polyethylene glycol 1000 trisodium ethylenediamine disuccinate betasizofiran pullulan ammonium acryloyldimethyltaurate/vp copolymer xanthan gum isocetyl stearate caprylyl glycol carbomer homopolymer, unspecified type cetearyl glucoside inulin lauryl carbamate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-30
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

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
  • 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, alcohol denat., glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate, sodium dodecylbenzenesulfonate, phenoxyethanol, phenylethyl resorcinol, adenosine, PEG-8 laurate, PEG-20, trisodium ethylenediamine disuccinate, sclerotium gum, pullulan, ammonium acryloyldimethyltaurate/vp copolymer, xanthan gum, isocetyl stearate, caprylyl glycol, carbomer, cetearyl glucoside, inulin lauryl carbamate

Description

Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Flammable Until Dry.

Do not use near fire, flame, or heat.

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
  • 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, alcohol denat., glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate, sodium dodecylbenzenesulfonate, phenoxyethanol, phenylethyl resorcinol, adenosine, PEG-8 laurate, PEG-20, trisodium ethylenediamine disuccinate, sclerotium gum, pullulan, ammonium acryloyldimethyltaurate/vp copolymer, xanthan gum, isocetyl stearate, caprylyl glycol, carbomer, cetearyl glucoside, inulin lauryl carbamate

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame, or heat.

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: 2026-02-15T12:05:07.568605 · Updated: 2026-03-14T23:06:27.679265