Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a3dc6195-3011-4e7f-b1b0-0c815b11ba8d
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Ethylhexyl Salicylate (72 mg) Octocrylene
Inactive Ingredients
Water Glycerin Dimethicone Silica Niacinamide Glyceryl Stearate Peg-100 Stearate Pentylene Glycol Dicaprylyl Carbonate Steareth-100 Stearic Acid Ceramide Np Myristic Acid Perlite Palmitic Acid Ammonium Polyacryloyldimethyl Taurate Capryloyl Salicylic Acid Caprylyl Glycol Citric Acid Trisodium Ethylenediamine Disuccinate Xanthan Gum Tocopherol Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-03
Description

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

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

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

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   
Section 51945-4

Warnings

For external use only

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, regulary 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
Do Not Use

on damaged or broken skin

Other Information
  • protect the producct in this container from excessive heat and direct sun
  • store at 20°-25°C (68° to 77° F)
Active Ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Inactive Ingredients

 water, glycerin, dimethicone, silica, niacinamide, glyceryl stearate, PEG-100 stearate, pentylene glycol, dicaprylyl carbonate, steareth-100, stearic acid, ceramide NP, dimethicone/vinyl dimethicone crosspolymer, myristic acid, perlite, palmitic acid, ammonium polyacryloyldimethyl taurate, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, tocopherol, phenoxyethanol

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

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   
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings

For external use only

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, regulary 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
Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • protect the producct in this container from excessive heat and direct sun
  • store at 20°-25°C (68° to 77° F)
Active Ingredients (Active ingredients)

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Inactive Ingredients (Inactive ingredients)

 water, glycerin, dimethicone, silica, niacinamide, glyceryl stearate, PEG-100 stearate, pentylene glycol, dicaprylyl carbonate, steareth-100, stearic acid, ceramide NP, dimethicone/vinyl dimethicone crosspolymer, myristic acid, perlite, palmitic acid, ammonium polyacryloyldimethyl taurate, capryloyl salicylic acid, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, xanthan gum, tocopherol, phenoxyethanol

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

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Source: dailymed · Ingested: 2026-02-15T12:06:25.509484 · Updated: 2026-03-14T23:09:12.253423