Drug Facts 

Drug Facts 
SPL v3
SPL
SPL Set ID dc85cff3-df18-4bb7-8d71-bb0878959fe2
Route
TOPICAL
Published
Effective Date 2025-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (80 mg) Octisalate (50 mg) Octocrylene (70 mg) Zinc Cation
Inactive Ingredients
Water Glycerin Dimethicone Propanediol Butyloctyl Salicylate Steareth-20 Powdered Cellulose Niacinamide Ethylhexyl Methoxycrylene Steareth-2 Ceramide Np Ceramide Ap Ceramide 1 Sorbitan Isostearate Carbomer Homopolymer, Unspecified Type Soybean Oil Triethoxycaprylylsilane Cetostearyl Alcohol Behentrimonium Methosulfate Triethyl Citrate Hyaluronate Sodium Sodium Lauroyl Lactylate Cholesterol Ammonium Polyacryloyldimethyl Taurate Tocopherol Chlorphenesin Hydroxyacetophenone Caprylyl Glycol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Trisodium Ethylenediamine Disuccinate Phytosphingosine Xanthan Gum Polyhydroxystearic Acid Stearate Polysorbate 60 Rice Bran Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01
Description

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc oxide 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 8% Octisalate 5% Octocrylene 5% Zinc oxide 7%

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 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 our 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               

Do Not Use

on damaged or broken skin

Other Information
  • protect the product in this container from excessive heat and direct sun
Active Ingredients

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients

water, glycerin, dimethicone, propanediol, butyloctyl salicylate, steareth-20, cellulose, niacinamide, ehtylhexyl methoxycrylene, steareth-2, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, glycine soja (soybean) oil, triethoxycaprylsilane, cetearyl alcohol, behentriminium methosulfate, triethyl citrate, sodium hyaluronate, sodium lauroryl lactylate, cholesterol, ammonium polyacryloyldimethyl taurate, tocopherol, chlorphenesin, hydroxyacetophenone, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisodium ethylenediamine disuccinate, phytosphingosine, xanthan gum, polyhydrostearic acid, polysorbate 60, oryza sativa (rice) bran wax, benzoic acid, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer

Question Or Comments?

Toll-free number  1-877-768-2915

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 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 our 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               

Do Not Use (Do not use)

on damaged or broken skin

Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, dimethicone, propanediol, butyloctyl salicylate, steareth-20, cellulose, niacinamide, ehtylhexyl methoxycrylene, steareth-2, ceramide NP, ceramide AP, ceramide EOP, sorbitan isostearate, carbomer, glycine soja (soybean) oil, triethoxycaprylsilane, cetearyl alcohol, behentriminium methosulfate, triethyl citrate, sodium hyaluronate, sodium lauroryl lactylate, cholesterol, ammonium polyacryloyldimethyl taurate, tocopherol, chlorphenesin, hydroxyacetophenone, caprylyl glycol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, trisodium ethylenediamine disuccinate, phytosphingosine, xanthan gum, polyhydrostearic acid, polysorbate 60, oryza sativa (rice) bran wax, benzoic acid, c12-22 alkyl acrylate/hydroxyethylacrylate copolymer

Question Or Comments? (Question or comments?)

Toll-free number  1-877-768-2915

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

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:49.469370 · Updated: 2026-03-14T23:08:08.103878