Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6dbbc8ce-9457-4405-bb38-aa0c7550c62c
Route
TOPICAL
Published
Effective Date 2024-06-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg) Octocrylene (70 mg)
Inactive Ingredients
Water C15-19 Alkane Niacinamide Glycerin Butylene Glycol Silicon Dioxide Titanium Dioxide Hydroxyacetophenone Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Potassium Hydroxide Sodium Thiosulfate Taraxacum Officinale Root Trisodium Ethylenediamine Disuccinate Shea Butter Ammonium Acryloyldimethyltaurate/vp Copolymer Arachidyl Alcohol Arachidyl Glucoside Docosanol Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Citric Acid Monohydrate Mica Pentylene Glycol Behenyl Acrylate Polymer Polyglyceryl-4 Caprate Sodium Dilauramidoglutamide Lysine Stannic Oxide Xanthan Gum Fd&c Red No. 4 Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-15
Description

Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% 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 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

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, C15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, potassium hydroxide, sodium thiosulfate, taraxacum officinale (dandelion) rhizome/root extract, trisodium ethylenediamine disuccinate, 2-mercaptonicotinoyl glycine, butyrospermum parkii (shea) butter, ammonium acryloyldimethyltaurate/VP copolymer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, caprylyl glycol, carbomer, citric acid, mica, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, sodium dilauramidoglutamide lysine, tin oxide, xanthan gum, red 4, phenoxyethanol

Questions Or Comments?

Call toll free 1-800-946-4453

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)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, C15-19 alkane, niacinamide, glycerin, butylene glycol, silica, titanium dioxide, hydroxyacetophenone, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, potassium hydroxide, sodium thiosulfate, taraxacum officinale (dandelion) rhizome/root extract, trisodium ethylenediamine disuccinate, 2-mercaptonicotinoyl glycine, butyrospermum parkii (shea) butter, ammonium acryloyldimethyltaurate/VP copolymer, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, caprylyl glycol, carbomer, citric acid, mica, pentylene glycol, poly c10-30 alkyl acrylate, polyglyceryl-4 caprate, sodium dilauramidoglutamide lysine, tin oxide, xanthan gum, red 4, phenoxyethanol

Questions Or Comments? (Questions or comments?)

Call toll free 1-800-946-4453

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: 2026-02-15T12:03:13.066306 · Updated: 2026-03-14T23:03:10.704753