drug facts

drug facts
SPL v2
SPL
SPL Set ID ed138c48-d542-4522-a23c-1b586aad1127
Route
topical
Published
Effective Date 2023-12-30
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 dimethicone alcohol silicon dioxide styrene/acrylamide copolymer (500000 mw) butyloctyl salicylate peg-30 dipolyhydroxystearate polymethylsilsesquioxane (4.5 microns) tocopherol phenoxyethanol peg-8 laurate lauryl peg/ppg-18/18 methicone sodium chloride caprylyl glycol isostearyl alcohol p-anisic acid pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) trisodium ethylenediamine disuccinate sodium dodecylbenzenesulfonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-01
Purpose

Sunscreen

Description

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

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, dimethicone, alcohol denat., silica, styrene/acrylates copolymer, butyloctyl salicylate, PEG-30 dipolyhydroxystearate, polymethylsilsesquioxane, tocopherol, phenoxyethanol, PEG-8 laurate, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, isostearyl alcohol, poly c10-30 alkyl acrylate, p-anisic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, trisodium ethylenediamine disuccinate, sodium dodecylbenzenesulfonate

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%

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, dimethicone, alcohol denat., silica, styrene/acrylates copolymer, butyloctyl salicylate, PEG-30 dipolyhydroxystearate, polymethylsilsesquioxane, tocopherol, phenoxyethanol, PEG-8 laurate, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, isostearyl alcohol, poly c10-30 alkyl acrylate, p-anisic acid, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, trisodium ethylenediamine disuccinate, sodium dodecylbenzenesulfonate

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%

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:37.339916 · Updated: 2026-03-14T23:02:16.200124