drug facts

drug facts
SPL v6
SPL
SPL Set ID a7c01228-02db-49a8-bb91-cee13fbd1df1
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 (130 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
water polymethylsilsesquioxane (4.5 microns) dimethicone glycerin dicaprylyl ether niacinamide behenyl acrylate polymer styrene/acrylamide copolymer (500000 mw) silicon dioxide caprylyl trisiloxane 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) diethylhexyl syringylidenemalonate glyceryl monostearate peg-100 stearate phenoxyethanol tocopherol potassium cetyl phosphate propylene glycol caprylyl glycol panthenol carbomer interpolymer type a (allyl sucrose crosslinked) trolamine peg-8 laurate chlorphenesin trisodium ethylenediamine disuccinate p-anisic acid medium-chain triglycerides xanthan gum senna alata leaf maltodextrin sodium dodecylbenzenesulfonate edetate disodium anhydrous

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-07-15
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 10%

Medication Information

Warnings

For external use only

Uses
  • helps prevent sunburn
  • if used as directed (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions

For sunscreen use:

  • apply generously 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 of 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, polymethylsilsesquioxane, dimethicone, glycerin, dicaprylyl ether, niacinamide, poly c10-30 alkyl acrylate, styrene/acrylates copolymer, silica, caprylyl methicone, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, glyceryl stearate, PEG-100 stearate, phenoxyethanol, tocopherol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, panthenol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl carbamate, chlorphenesin, trisodium ethylenediamine disuccinate, p-anisic acid, caprylic/capric triglyceride, xanthan gum, cassia alata leaf extract, maltodextrin, sodium dodecylbenzenesulfonate, disodium EDTA

Description

Avobenzone 3% Homosalate 13% Octisalate 5% Octocrylene 10%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 10%

Questions Or Comments?

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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 (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Purpose

Sunscreen

Directions

For sunscreen use:

  • apply generously 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 of 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, polymethylsilsesquioxane, dimethicone, glycerin, dicaprylyl ether, niacinamide, poly c10-30 alkyl acrylate, styrene/acrylates copolymer, silica, caprylyl methicone, acrylates/dimethicone copolymer, diethylhexyl syringylidenemalonate, glyceryl stearate, PEG-100 stearate, phenoxyethanol, tocopherol, potassium cetyl phosphate, propylene glycol, caprylyl glycol, panthenol, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, PEG-8 laurate, inulin lauryl carbamate, chlorphenesin, trisodium ethylenediamine disuccinate, p-anisic acid, caprylic/capric triglyceride, xanthan gum, cassia alata leaf extract, maltodextrin, sodium dodecylbenzenesulfonate, disodium EDTA

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 10%

Questions Or Comments? (Questions or comments?)

1-888-LRP-LABO  1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

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: 2026-02-15T12:02:38.044152 · Updated: 2026-03-14T23:02:18.218337