Label: LIGHTENING NIGHT CREAM- ethyl macadamiate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/12

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  • ACTIVE INGREDIENT

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

    LIGHTENING NIGHT CREAM LANGE
    This lightening and moisturizing formula helps to:
    Inhibit skin pigmentation,
    Nourish and moisturize,
    Soften and refine skin texture.
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
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  • INDICATIONS & USAGE

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

    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.
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  • DOSAGE & ADMINISTRATION

    50 ml
    1.7 FL. OZ
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  • INACTIVE INGREDIENT

    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 Close
  • PRINCIPAL DISPLAY PANEL

    image of carton label
    LANGE
    PARIS
    LIGHTENING NIGHT CREAM
    Moonlight with Seaweed extracts
    50 ml
    1.7 FL. OZ
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  • INGREDIENTS AND APPEARANCE
    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)
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