Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 46aa9917-52ac-4c57-afde-366d2d3ca200
Route
TOPICAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (70 mg) Ethylhexyl Salicylate (50 mg) Octocrylene
Inactive Ingredients
Water Glycerin C15-19 Alkane Niacinamide Propanediol Tocopherol Sodium Stearoyl Glutamate Cetearyl Alcohol Sclerotium Gum Hydroxyacetophenone Caprylyl Glycol Glyceryl Stearate Hydrolyzed Jojoba Esters Helianthus Annuus (sunflower) Seed Wax Trisodium Ethylenediamine Disuccinate Pentylene Glycol Diethylhexyl Syringylidenemalonate Maltodextrin Sodium Hydroxide Caprylic/capric Triglyceride Polyglycerin-3 Citric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-11
Description

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

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 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 generously 15 minutes before sun exposure

· reaply 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 the 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 7%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients

water, glycerin, C15-19 alkane, niacinamide, propanediol, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, tocopherol, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, pentylene glycol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, sodium hydroxide, caprylic/capric triglyceride, polyglycerin-3, citric acid

Questions Or Comments?

1-888- LRP-LABO  1-888-577-5226

Monday - Friday (9a.m. -5 p.m. EST)

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

· reaply 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 the 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 7%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (Inactive ingredients)

water, glycerin, C15-19 alkane, niacinamide, propanediol, C12-22 alkyl acrylate/hydroxyethylacrylate copolymer, tocopherol, sodium stearoyl glutamate, cetearyl alcohol, sclerotium gum, hydroxyacetophenone, caprylyl glycol, sodium starch octenylsuccinate, glyceryl stearate, jojoba esters, helianthus annuus (sunflower) seed wax, hydroxypropyl starch phosphate, trisodium ethylenediamine disuccinate, pentylene glycol, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, sodium hydroxide, caprylic/capric triglyceride, polyglycerin-3, citric acid

Questions Or Comments? (Questions or comments?)

1-888- LRP-LABO  1-888-577-5226

Monday - Friday (9a.m. -5 p.m. EST)

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: 2026-02-15T12:05:01.243818 · Updated: 2026-03-14T23:06:18.731306