Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 8e48e675-0b4f-4b91-85de-c4e29be65147
Route
TOPICAL
Published
Effective Date 2024-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (36 mg)
Inactive Ingredients
Dimethicone Water Isododecane Alcohol Trimethylsiloxysilicate (m/q 0.6-0.8) Propylene Glycol Glycerin Peg/ppg-18/18 Dimethicone Silicon Dioxide Magnesium Potassium Aluminosilicate Fluoride Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Rosa Gallica Flower Sorbitol Mandelic Acid Peg-10 Dimethicone (600 Cst) .alpha.-glucan Oligosaccharide Sodium Chloride Hyaluronate Sodium Sodium Hydroxide Aluminum Hydroxide Ammonium Polyacryloyldimethyl Taurate (55000 Mpa.s) Sodium Phosphate, Dibasic, Anhydrous Disodium Stearoyl Glutamate Hydroxyethylpiperazine Ethane Sulfonic Acid Caprylyl Glycol Citric Acid Monohydrate Maltodextrin Polyvinyl Alcohol, Unspecified Butylene Glycol Tocopherol Phenoxyethanol Linalool, (+/-)- Geraniol Limonene, (+)- Citral .beta.-citronellol, (r)- Benzyl Alcohol Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-05-01 Until 2027-05-16

Description

Ensulizole 3.6%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ensulizole 3.6%

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

●  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 3.6%

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, glycerin, PEG/PPG-18/18 dimethicone, silica, synthetic fluorphlogopite, polysilicone-11, rosa gallica flower extract, moringa oleifera seed extract, polymnia sonchifolia root juice, sorbitol, mandelic acid, PEG-10 dimethicone, alpha-glucan oligosaccharide. sodium chloride, sodium hyaluronate, sodium hydroxide, silica silylate, cellulose acetate butyrate, aluminum hydroxide, ammonium polyacryloyldimethyl taurate, disodium phosphate, disodium stearoyl glutamate, hydroxyethylpiperazine ethane sulfonic acid, caprylyl glycol, citric acid, lactobacillus, maltodextrin, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, butylene glycol, tocopherol, phenoxyethanol, fragrance, linalool, geraniol, limonene, citral, citronellol, benzyl alcohol; may contain: titanium dioxide, iron oxides

Questions Or Comments?

1-800-LANCOME

(1-800-526-2663)

Monday - Friday

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

When Using This Product

keep out of eyes. Rinse with wate 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

●  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 3.6%

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, glycerin, PEG/PPG-18/18 dimethicone, silica, synthetic fluorphlogopite, polysilicone-11, rosa gallica flower extract, moringa oleifera seed extract, polymnia sonchifolia root juice, sorbitol, mandelic acid, PEG-10 dimethicone, alpha-glucan oligosaccharide. sodium chloride, sodium hyaluronate, sodium hydroxide, silica silylate, cellulose acetate butyrate, aluminum hydroxide, ammonium polyacryloyldimethyl taurate, disodium phosphate, disodium stearoyl glutamate, hydroxyethylpiperazine ethane sulfonic acid, caprylyl glycol, citric acid, lactobacillus, maltodextrin, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, butylene glycol, tocopherol, phenoxyethanol, fragrance, linalool, geraniol, limonene, citral, citronellol, benzyl alcohol; may contain: titanium dioxide, iron oxides

Questions Or Comments? (Questions or comments?)

1-800-LANCOME

(1-800-526-2663)

Monday - Friday

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

When Using This Product (When using this product)

keep out of eyes. Rinse with wate 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

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