PRADA REVEAL SKIN OPTIMIZING FOUNDATION BROAD SPECTRUM SPF 17 SUNSCREEN- ensulizole liquid 
SICOS ET CIE

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Drug Facts

Active ingredient

Ensulizole 2.7%

Purpose

Sunscreen

Uses

Warnings

For external use only

Flammable until dry.

Do not use near fire, flame or heat.

Do not use

on damaged or broken skin

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.

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

Other information

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

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

image of a carton

image of a carton
PRADA REVEAL SKIN OPTIMIZING FOUNDATION BROAD SPECTRUM SPF 17 SUNSCREEN 
ensulizole liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51150-380
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE27 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
ALCOHOL (UNII: 3K9958V90M)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LACTOBACILLUS ACIDOPHILUS BCMC 12130 (UNII: MVC2243UZX)  
GERANIOL (UNII: L837108USY)  
CITRONELLOL ACETATE, (S)- (UNII: 78RZL4H51H)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51150-380-011 in 1 CARTON06/01/2023
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:51150-380-023 mL in 1 PACKAGE; Type 0: Not a Combination Product06/01/2023
3NDC:51150-380-031 mL in 1 PACKET; Type 0: Not a Combination Product06/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/01/2023
Labeler - SICOS ET CIE (276993581)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(51150-380)
Establishment
NameAddressID/FEIBusiness Operations
BPS 60272259304pack(51150-380)
Establishment
NameAddressID/FEIBusiness Operations
Socoplan276221405pack(51150-380)

Revised: 12/2023
Document Id: e04f6a9e-a55e-482a-b0df-5fe013288910
Set id: 1ac50772-0bea-4a41-8300-03f65f0bed52
Version: 1
Effective Time: 20231218
 
SICOS ET CIE