Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 7f960d4c-ad09-4dc8-b272-66e4df26ace8
Route
TOPICAL
Published
Effective Date 2024-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (50 mg) Octisalate (70 mg) Octocrylene
Inactive Ingredients
Water Glycerin Silicon Dioxide Dimethicone Peg-100 Stearate Glyceryl Monostearate Cannabis Sativa Seed Oil Stearic Acid Phenoxyethanol Palmitic Acid Ammonium Polyacryloyldimethyl Taurate Steareth-100 Phenylethyl Resorcinol Capryloyl Salicylic Acid Caprylyl Glycol Xanthan Gum Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Edetate Disodium Hyaluronate Sodium Tocopherol Dipropylene Glycol Ascorbyl Glucoside Myristic Acid Sodium Palmitoyl Proline Sodium Hydroxide Centella Asiatica Butylene Glycol Linalool, (+)- Geraniol Limonene, (+)- Nymphaea Alba Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-04-01
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 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 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, cannabis sativa seed oil, stearic acid, phenoxyethanol, palmitic acid, ammonium polyacryloyldimethyl taurate, steareth-100, phenylethyl resorcinol, caprylyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, fragrance, sodium hyaluronate, tocopherol, dipropylene glycol, ascorbyl glucoside, myristic acid, sodium palmitoyl proline, sodium hydroxide, centella asiatica extract, butylene glycol, linalool, geraniol, limonene, nymphaea alba flower extract

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 5%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, cannabis sativa seed oil, stearic acid, phenoxyethanol, palmitic acid, ammonium polyacryloyldimethyl taurate, steareth-100, phenylethyl resorcinol, caprylyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, fragrance, sodium hyaluronate, tocopherol, dipropylene glycol, ascorbyl glucoside, myristic acid, sodium palmitoyl proline, sodium hydroxide, centella asiatica extract, butylene glycol, linalool, geraniol, limonene, nymphaea alba flower extract

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: 2026-02-15T12:02:42.575213 · Updated: 2026-03-14T23:02:24.469183