Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 913116de-1abf-4844-8611-1db1b093ad00
Route
TOPICAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ensulizole (35 mg)
Inactive Ingredients
Water Glycerin Caprylyl Trisiloxane Propanediol Dimethicone Pentylene Glycol Dimethicone/peg-10/15 Crosspolymer Sodium Hydroxide Sodium Chloride Phenoxyethanol Isopropyl Titanium Triisostearate Chlorphenesin Edetate Disodium Anhydrous Aloe Vera Leaf Hamamelis Virginiana Top Water Aluminum Oxide Butylene Glycol Stearic Acid Aluminum Hydroxide Dipropylene Glycol Alcohol Hyaluronate Sodium Sodium Citrate Limonene, (+)- .beta.-citronellol, (r)- Tocopherol Ginger Sanguisorba Officinalis Root Chinese Cinnamon Citric Acid Monohydrate Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-01

Description

Ensulizole 3.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Ensulizole 3.5%

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 using

● 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 3.5%

Other Information

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

Inactive Ingredients

water, glycerin, caprylyl methicone, propanediol, dimethicone, pentylene glycol, dimethicone/PEG-10/15 crosspolymer, sodium hydroxide, sodium chloride, phenoxyethanol, triethoxysilylethyl polydimethylsiloxyethyl dimethicone, isopropyl titanium triisostearate, chlorphenesin, disodium EDTA, aloe barbadensis leaf juice powder, hamamelis virginiana (witch hazel) water, alumina, butylene glycol, fragrance,

stearic acid, aluminum hydroxide, dipropylene glycol, alcohol, sodium hyaluronate, sodium citrate, limonene, citronellol, tocopherol, zingiber officinale (ginger) root extract

sanguisorba officinalis root extract, cinnamomum cassia bark extract, citric acid; may contain: titanium dioxide, iron oxides

Questions Or Comments?

1-800-322-2036

Monday - Friday

(10 a.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:

● shake well before using

● 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 3.5%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, glycerin, caprylyl methicone, propanediol, dimethicone, pentylene glycol, dimethicone/PEG-10/15 crosspolymer, sodium hydroxide, sodium chloride, phenoxyethanol, triethoxysilylethyl polydimethylsiloxyethyl dimethicone, isopropyl titanium triisostearate, chlorphenesin, disodium EDTA, aloe barbadensis leaf juice powder, hamamelis virginiana (witch hazel) water, alumina, butylene glycol, fragrance,

stearic acid, aluminum hydroxide, dipropylene glycol, alcohol, sodium hyaluronate, sodium citrate, limonene, citronellol, tocopherol, zingiber officinale (ginger) root extract

sanguisorba officinalis root extract, cinnamomum cassia bark extract, citric acid; may contain: titanium dioxide, iron oxides

Questions Or Comments? (Questions or comments?)

1-800-322-2036

Monday - Friday

(10 a.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

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