Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 1c83726b-f8ff-48d5-bf30-bc75e3fb149d
Route
TOPICAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (27 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Cyclomethicone 6 Isononyl Isononanoate Isohexadecane Glyceryl Monostearate Shea Butter Peg-100 Stearate Butylene Glycol Polyoxyl 20 Cetostearyl Ether Phenoxyethanol Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Caprylyl Glycol Tocopherol Chlorphenesin Xanthan Gum Edetate Disodium Titanium Dioxide Mica P-anisic Acid Paeonia Lactiflora Root Bismuth Oxychloride Ferric Oxide Red Adenosine Iris X Germanica Nothovar. Florentina Root Sodium Hydroxide Stannic Oxide .alpha.-hexylcinnamaldehyde Benzyl Alcohol Hydroxycitronellal Benzyl Salicylate Linalool, (+/-)- .beta.-citronellol, (r)- Limonene, (+)- Geraniol Isomethyl-.alpha.-ionone Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-15
Description

Avobenzone 3% Homosalate 2.7% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 2.7% 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 suncreen 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 shrits, pants, hat 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 2.7%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, butylene glycol, ceteareth-20, phenoxyethanol, synthetic fluorphlogopite, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, titanium dioxide, mica, fragrance, p-anisic acid, paeonia albiflora root extract, bismuth oxychloride, iron oxides, adenosine, iris florentina root extract, sodium hydroxide, tin oxide, hexyl cinnamal, benzyl alcohol, hydroxycitrinellal, benzyl salicylate, linalool, citronellol, limonene, geraniol, alpha-isomethyl ionone, citric acid

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 suncreen 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 shrits, pants, hat 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 2.7%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, cetearyl alcohol, isohexadecane, glyceryl stearate, cyclohexasiloxane, isononyl isononanoate, butyrospermum parkii (shea) butter, PEG-100 stearate, butylene glycol, ceteareth-20, phenoxyethanol, synthetic fluorphlogopite, ammonium polyacryloyldimethyl taurate, caprylyl glycol, tocopherol, chlorphenesin, xanthan gum, disodium EDTA, titanium dioxide, mica, fragrance, p-anisic acid, paeonia albiflora root extract, bismuth oxychloride, iron oxides, adenosine, iris florentina root extract, sodium hydroxide, tin oxide, hexyl cinnamal, benzyl alcohol, hydroxycitrinellal, benzyl salicylate, linalool, citronellol, limonene, geraniol, alpha-isomethyl ionone, citric acid

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: 2026-02-15T12:02:36.539146 · Updated: 2026-03-14T23:02:16.200124