Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 7d9e8c07-d295-4c8e-a52f-bdb509dc489b
Route
TOPICAL
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Ethylhexyl Methoxycinnamate (50 mg) Ethylhexyl Salicylate (20 mg) Octocrylene (80 mg) Zinc Cation
Inactive Ingredients
Water Niacinamide Cetearyl Alcohol Glycerin Propanediol Dimethicone Behentrimonium Methosulfate Bht Ceramide Np Ceramide Ap Carbomer Triethoxycaprylylsilane Triethyl Citrate Sodium Lauroyl Lactylate Sodium Hyaluronate Sodium Phosphate Cholesterol Aluminum Starch Octenylsuccinate Phenoxyethanol Disodium Phosphate Hydroxyethylcellulose Hydroxyacetophenone Caprylyl Glycol Trisodium Ethylenediamine Disuccinate Phytosphingosine Xanthan Gum Polysorbate 60 Benzoic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-19
Description

Homosalate 10% Octinoxate 5% Octisalate 5% Octocrylene 2% Zinc oxide 8%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Homosalate 10% Octinoxate 5% Octisalate 5% Octocrylene 2% Zinc oxide 8%

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 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 Not Use

on damaged or broken skin

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

Homosalate 10%

Octinoxate 5%

Octisalate 5%

Octocrylene 2%

Zinc oxide 8%

Inactive Ingredients

water, niacinamide, cetearyl alcohol, glycerin, propanediol, dimethicone, behentrimonium methosulfate, BHT, ceramide NP, ceramide AP, ceramide EOP, carbomer, triethoxycaprylylsilane, triethyl citrate, sodium lauroyl lactylate, sodium hyaluronate, sodium phosphate, cholesterol, aluminum starch octenylsuccinate, phenoxyethanol, disodium phosphate, hydroxyethylcellulose, hydroxyacetophenone, caprylyl glycol, trisodium ethylenediamine disuccinate, phytosphingosine, xanthan gum, polysorbate 60, benzoic acid

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 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. - 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 10%

Octinoxate 5%

Octisalate 5%

Octocrylene 2%

Zinc oxide 8%

Inactive Ingredients (Inactive ingredients)

water, niacinamide, cetearyl alcohol, glycerin, propanediol, dimethicone, behentrimonium methosulfate, BHT, ceramide NP, ceramide AP, ceramide EOP, carbomer, triethoxycaprylylsilane, triethyl citrate, sodium lauroyl lactylate, sodium hyaluronate, sodium phosphate, cholesterol, aluminum starch octenylsuccinate, phenoxyethanol, disodium phosphate, hydroxyethylcellulose, hydroxyacetophenone, caprylyl glycol, trisodium ethylenediamine disuccinate, phytosphingosine, xanthan gum, polysorbate 60, benzoic acid

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:47.682074 · Updated: 2026-03-14T23:08:06.304944