Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3676aa91-c90d-4a7a-b02e-d5b35304a04d
Route
TOPICAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Ethylhexyl Salicylate (70 mg) Octocrylene
Inactive Ingredients
Water Glycerin Niacinamide Dimethicone Aluminum Starch Octenylsuccinate Isopropyl Isostearate Isohexadecane Squalane Boron Nitride Potassium Hydroxide Ceramide Np Ceramide Ap Carbomer Sorbitan Oleate Glyceryl Stearate Behenyl Alcohol Cetearyl Alcohol Cetearyl Glucoside Triethyl Citrate Behentrimonium Methosulfate Sodium Acrylate/sodium Acryloyldimethyltaurate Copolymer (4000000 Mw) Sodium Hyaluronate Sodium Thiosulfate Sodium Lauroyl Lactylate Cholesterol Phenoxyethanol Carnosine Ammonium Acryloyldimethyltaurate/vp Copolymer Tocopherol Hydroxyacetophenone Caprylyl Glycol Trisodium Ethylenediamine Disuccinate Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate Phytosphingosine Xanthan Gum Cetyl Alcohol Polysorbate 80 Benzoic Acid Peg-100 Stearate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 5% Octisalate 5% Octocrylene 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 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 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 No Use

on damaged or broken skin

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

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, niacinamide, dimethicone, aluminum starch octenylsuccinate, isopropyl isostearate, isohexadecane, squalane, boron nitride, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, sorbitan oleate, glyceryl stearate, behenyl alcohol, 2-mercaptonicotinoyl glycine, cetearyl alcohol, cetearyl glucoside, triethyl citrate, behentrimonium methosulfate, sodium acrylate/ sodium acryloyldimethyl taurate copolymer, sodium hyaluronate, sodium thiosulfate, sodium lauroyl lactylate, cholesterol, phenoxyethanol, carnosine, ammonium acryloyldimethyltaurate/VP copolymer, tocopherol, hydroxyacetophenone, caprylyl glycol, trisodium ethylenediamine disuccinate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phytosphingosine, xanthan gum, cetyl alcohol, polysorbate 80, benzoic acid, PEG-100 stearate

Questions Or Comments?

Toll-free number  1-888-768-2915

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 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 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 No Use (Do no use)

on damaged or broken skin

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

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, niacinamide, dimethicone, aluminum starch octenylsuccinate, isopropyl isostearate, isohexadecane, squalane, boron nitride, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, sorbitan oleate, glyceryl stearate, behenyl alcohol, 2-mercaptonicotinoyl glycine, cetearyl alcohol, cetearyl glucoside, triethyl citrate, behentrimonium methosulfate, sodium acrylate/ sodium acryloyldimethyl taurate copolymer, sodium hyaluronate, sodium thiosulfate, sodium lauroyl lactylate, cholesterol, phenoxyethanol, carnosine, ammonium acryloyldimethyltaurate/VP copolymer, tocopherol, hydroxyacetophenone, caprylyl glycol, trisodium ethylenediamine disuccinate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, phytosphingosine, xanthan gum, cetyl alcohol, polysorbate 80, benzoic acid, PEG-100 stearate

Questions Or Comments? (Questions or comments?)

Toll-free number  1-888-768-2915

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.


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