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

Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen by

Drug Labeling and Warnings

Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, BPS 60, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ensulizole 2.7%

Purpose

Sunscreen

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRADA REVEAL SKIN OPTIMIZING FOUNDATION BROAD SPECTRUM SPF 17 SUNSCREEN 
ensulizole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-380
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-380-01	1 in 1 CARTON	06/01/2023	05/14/2027
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-380-02	3 mL in 1 PACKAGE; Type 0: Not a Combination Product	06/01/2023	02/28/2027
3	NDC: 49967-380-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	06/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2023

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-380)

Establishment
Name	Address	ID/FEI	Business Operations
BPS 60		272259304	pack(49967-380)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-380)