LUMASILK EMULSION LEVEL 02- lumasilk emulsion level 02 emulsion
The Skin Atelier, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient: 2% Hydroquinone

Directions: Wash face then apply to entire face morning and evening, avoiding the eye area.

Directions: Wash face then apply to entire face moring and evening, avoiding the eye area.

For external use only. When using this product avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed get medical help or call Poison Control Center immediately.

Inactive Ingredients: Water, Alcohol SDA 40B, Squalane, Coenochloris Signiensis Extract (and) Maltodextrin (and) Lecithin, sodium Hyaluronate, Glycerin, dimethicone, Niacinimide, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Caprylhydroxamic Acid, Glyceryl Caprylate, Bidens Pilosa Extract, Elaeis Guineensis (Palm) Oil, Gossypium Herbaceum (Cotton) Seed Oil, Linum Usitatissimum (Linseed) Seed Oil, Sodium Stearoyl Lactylate, Cetyl Alcohol, Olus Oil/Vegetable Oil, Tocopheryl Acetate, Glycine Soja/Glycine Soja, (Soybean) Sterols, Sodium Carboxymethyl Betaglucan, Sodium Lactate, Carnosine, Phenyethylalcohol, sodium metabisulfite, disodium EDTA

Lightens skin. Restores skin luminosity. Instantly smoothes and softens skin.

Keep out of reach of children. If swallowed get medical help or call Poison Control Center immediately.

LUMASILK EMULSION LEVEL 02
lumasilk emulsion level 02 emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71393-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	0.02 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
ELAEIS GUINEENSIS FRUIT BUTTER (UNII: UYH3R74N56)
CORN OIL (UNII: 8470G57WFM)
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)
SODIUM LACTATE (UNII: TU7HW0W0QT)
CARNOSINE (UNII: 8HO6PVN24W)
GOSSYPIUM HERBACEUM WHOLE (UNII: 9DK7DJK0D6)
CETYL ALCOHOL (UNII: 936JST6JCN)
DISODIUM HEDTA (UNII: KME849MC7A)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
NIACINAMIDE (UNII: 25X51I8RD4)
LINUM USITATISSIMUM WHOLE (UNII: 310OJT00CG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SOYBEAN OIL (UNII: 241ATL177A)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BIDENS PILOSA LEAF (UNII: 457932TMZ8)
DIMETHICONE 200 (UNII: RGS4T2AS00)
SQUALANE (UNII: GW89575KF9)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)
GLYCERYL CAPRATE (UNII: 197M6VFC1W)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
COENOCHLORIS SIGNIENSIS (UNII: G5P2RJVPDJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71393-005-30	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/01/2017	10/11/2019

Labeler - The Skin Atelier, Inc. (135049810)

Name	Address	ID/FEI	Business Operations
Establishment
The Skin Atelier, Inc.		135049810	manufacture(71393-005)

Revised: 1/2020

Document Id: 9c58e0ba-aac7-54ee-e053-2995a90a8f1c

Set id: 51c7d6d4-3651-0a53-e054-00144ff88e88

Version: 2

Effective Time: 20200117

The Skin Atelier, Inc.