Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID e74a8c43-ec70-4de1-b2b5-0e89e40bfb40
Route
TOPICAL
Published
Effective Date 2025-07-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (27 mg)
Inactive Ingredients
Dimethicone Water Isododecane Alcohol Trimethylsiloxysilicate (m/q 0.6-0.8) Propylene Glycol Peg/ppg-18/18 Dimethicone Glycerin Niacinamide Silicon Dioxide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Hydroxyethylpiperazine Ethane Sulfonic Acid Sodium Chloride Phenoxyethanol Peg-10 Dimethicone (600 Cst) Sodium Hydroxide Disodium Stearoyl Glutamate Tocopherol .alpha.-glucan Oligosaccharide Aluminum Hydroxide Limonene, (+)- Maltodextrin Isomethyl-.alpha.-ionone Lactobacillus Acidophilus Bcmc 12130 Geraniol Citronellol Acetate, (s)- Citric Acid Monohydrate Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-06-01 Until 2027-02-28
Description

Ensulizole 2.7%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Ensulizole 2.7%

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:

● shake well before 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

Active Ingredient

Ensulizole 2.7%

Other Information

protect the product in this container from excessive heat and direct sun

Flammable Until Dry.

Do not use near fire, flame or heat.

Inactive Ingredients

dimethicone, water, isododecane, alcohol denat., trimethylsiloxysilicate, propylene glycol, PEG/PPG-18/18 dimethicone, glycerin, niacinamide, silica, synthetic fluorphlogopite, polysilicone-11, hydroxyethylpiperazine ethane sulfonic acid, sodium chloride, phenoxyethanol, PEG-10 dimethicone, silica silylate, sodium hydroxide, disodium stearoyl glutamate, tocopherol, fragrance, alpha-glucan oligosaccharide, aluminum hydroxide, polymnia sonchifolia root juice, limonene, maltodextrin, alpha-isomethyl ionone, lactobacillus, geraniol, citronellol, citric acid; may contain: titanium dioxide, iron oxides

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:

● shake well before 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

Active Ingredient (Active ingredient)

Ensulizole 2.7%

Other Information (Other information)

protect the product in this container from excessive heat and direct sun

Flammable Until Dry. (Flammable until dry.)

Do not use near fire, flame or heat.

Inactive Ingredients (Inactive ingredients)

dimethicone, water, isododecane, alcohol denat., trimethylsiloxysilicate, propylene glycol, PEG/PPG-18/18 dimethicone, glycerin, niacinamide, silica, synthetic fluorphlogopite, polysilicone-11, hydroxyethylpiperazine ethane sulfonic acid, sodium chloride, phenoxyethanol, PEG-10 dimethicone, silica silylate, sodium hydroxide, disodium stearoyl glutamate, tocopherol, fragrance, alpha-glucan oligosaccharide, aluminum hydroxide, polymnia sonchifolia root juice, limonene, maltodextrin, alpha-isomethyl ionone, lactobacillus, geraniol, citronellol, citric acid; may contain: titanium dioxide, iron oxides

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: 2026-02-15T12:06:29.100108 · Updated: 2026-03-14T23:09:16.713853