LIGHTENING NIGHT CREAM- ethyl macadamiate cream 
LANGE SAS

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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KEY ACTIVE INGREDIENTS
Seaweed, Monoi, Licorice and Pearl Protein Extracts

LIGHTENING NIGHT CREAM LANGE
This lightening and moisturizing formula helps to:
Inhibit skin pigmentation,
Nourish and moisturize,
Soften and refine skin texture.

Keep out of reach of children.

This Whitening Seaweed inhibits melanin synthesis and reduces pigmentation of synthesized melanins with elimination of pigmented scales.

WARNING!
Avoid contact with the eyes;
Avoid or afford protecting from UV
whilst using products containing AHA
because of the suggestion of susceptibility to
increased damage from UV.

50 ml
1.7 FL. OZ

WATER
PEG-8
GLYCERIN
CAPRYLIC/CAPRIC TRIGLYCERIDE
ARACHIDYL ALCOHOL
METHYL GLUCETH-20
ETHYL MACADAMIATE
BEHENYL ALCOHOL
CAMELLIA KISSI SEED OIL
HEXYLDECANOL
HEXYLDECYL LAURATE
SODIUM POLYACRYLATE
PROPYLENE GLYCOL
CYCLOPENTASILOXANE
ARACHIDYL GLUCOSIDE
PHENOXYETHANOL
HYDROGENATED COCONUT OIL
SODIUM PCA
DISODIUM EDTA
PROPYLPARABEN
DIMETHICONOL
METHYLPARABEN
MAGNESIUM ASCORBYL PHOSPHATE
o-CYMEN-5-OL
TROMETHAMINE
ETHYLPARABEN
GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT
CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT
GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL
BUTYLENE GLYCOL
TOCOPHEROL
GLYCERYL POLYACRYLATE
BAMBUSA VULGARIS EXTRACT
PANAX GINSENG ROOT EXTRACT
GARDENIA TAHITENSIS FLOWER
IRIS FLORENTINA ROOT EXTRACT
ASCOPHYLLUM NODOSUM EXTRACT

image of carton label
LANGE
PARIS
LIGHTENING NIGHT CREAM
Moonlight with Seaweed extracts
50 ml
1.7 FL. OZ
LIGHTENING NIGHT CREAM 
ethyl macadamiate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-020
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHYL MACADAMIATE (UNII: ANA2NCS6V1) (ETHYL MACADAMIATE - UNII:ANA2NCS6V1) ETHYL MACADAMIATE 1 mg  in 50 mg
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
DOCOSANOL (UNII: 9G1OE216XY)  
CAMELLIA KISSII SEED OIL (UNII: 96HGN0T99A)  
HEXYLDECANOL (UNII: 151Z7P1317)  
HEXYLDECYL LAURATE (UNII: 0V595C1P6M)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
TANGERINE (UNII: KH3E3096OO)  
ACRYLIC ACID (UNII: J94PBK7X8S)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)  
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51830-020-05 50 mg in 1 BOX
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/18/2012
Labeler - LANGE SAS (275956105)
Registrant - LANGE SAS (275956105)
Establishment
Name Address ID/FEI Business Operations
LANGE SAS 275956105 manufacture(51830-020)

Revised: 7/2012
Document Id: 618e21fc-0327-4292-a3a5-4ecfa0e31369
Set id: 319afd46-a188-4941-982f-1b5e45158991
Version: 2
Effective Time: 20120718
 
LANGE SAS