drug facts

drug facts
SPL v2
SPL
SPL Set ID f2990320-b61d-40b8-ba79-18d6b37e7f52
Route
topical
Published
Effective Date 2024-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (50 mg) titanium dioxide (28 mg) ensulizole (30 mg)
Inactive Ingredients
water dimethicone isododecane butylene glycol silicon dioxide cetyl peg/ppg-10/1 dimethicone (hlb 4) glycerin isohexadecane niacinamide trimethylsiloxysilicate (m/q 0.6-0.8) magnesium potassium aluminosilicate fluoride butyloctyl salicylate dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) sodium chloride aluminum starch octenylsuccinate phenoxyethanol disodium stearoyl glutamate sorbitan isostearate polyglyceryl-4 isostearate sodium hydroxide aluminum hydroxide hexyl laurate stearic acid chlorphenesin caprylyl glycol lentil trisodium ethylenediamine disuccinate hyaluronate sodium tocopherol adenosine kaolin ethylhexylglycerin steareth-20 pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) chlorhexidine gluconate n-hydroxysuccinimide sodium citrate potassium sorbate palmitoyl tripeptide-1 chrysin palmitoyl tetrapeptide-7 citric acid monohydrate biotin ferric oxide red

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-02-01

Purpose

Sunscreen

Description

Ensulizole 3% Octisalate 5% Titanium dioxide 2.8%


Medication Information

Warnings

For external use only

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

Purpose

Sunscreen

Directions

● 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

Other Information

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

Inactive Ingredients

water, dimethicone, isododecane, butylene glycol, silica, cetyl PEG/PPG-10/1 dimethicone, glycerin, isohexadecane, niacinamide, trimethylsiloxysilicate, synthetic fluorphlogopite, butyloctyl salicylate, dimethicone crosspolymer, sodium chloride, aluminum starch octenylsuccinate, phenoxyethanol, silica silylate, disodium stearoyl glutamate, sorbitan isostearate, polyglyceryl-4 isostearate, sodium hydroxide, aluminum hydroxide, hexyl laurate, stearic acid, chlorphenesin, caprylyl glycol, lens esculenta (lentil) seed extract, trisodium ethylenediamine disuccinate, sodium hyaluronate, tocopherol, adenosine, kaolin, ethylhexylglycerin, steareth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, potassium sorbate, palmitoyl tripeptide-1, chrysin, palmitoyl tetrapeptide-7, citric acid, biotin; may contain titanium dioxide, iron oxides

Description

Ensulizole 3% Octisalate 5% Titanium dioxide 2.8%

Section 51945-4

Do Not Use

on damaged or broken skin

Active Ingredients

Ensulizole 3%

Octisalate 5%

Titanium dioxide 2.8%

Questions Or Comments?

Call 800-620-3950

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

Warnings

For external use only

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

Purpose

Sunscreen

Directions

● 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

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

water, dimethicone, isododecane, butylene glycol, silica, cetyl PEG/PPG-10/1 dimethicone, glycerin, isohexadecane, niacinamide, trimethylsiloxysilicate, synthetic fluorphlogopite, butyloctyl salicylate, dimethicone crosspolymer, sodium chloride, aluminum starch octenylsuccinate, phenoxyethanol, silica silylate, disodium stearoyl glutamate, sorbitan isostearate, polyglyceryl-4 isostearate, sodium hydroxide, aluminum hydroxide, hexyl laurate, stearic acid, chlorphenesin, caprylyl glycol, lens esculenta (lentil) seed extract, trisodium ethylenediamine disuccinate, sodium hyaluronate, tocopherol, adenosine, kaolin, ethylhexylglycerin, steareth-20, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, chlorhexidine digluconate, n-hydroxysuccinimide, sodium citrate, potassium sorbate, palmitoyl tripeptide-1, chrysin, palmitoyl tetrapeptide-7, citric acid, biotin; may contain titanium dioxide, iron oxides

Section 51945-4 (51945-4)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients (Active ingredients)

Ensulizole 3%

Octisalate 5%

Titanium dioxide 2.8%

Questions Or Comments? (Questions or comments?)

Call 800-620-3950

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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