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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

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

    Keep out of reach of children.
    Close
  • INDICATIONS & USAGE

    This Whitening Seaweed inhibits melanin synthesis and reduces pigmentation of synthesized melanins with elimination of pigmented scales.
    Close
  • 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.
    Close
  • DOSAGE & ADMINISTRATION

    50 ml
    1.7 FL. OZ
    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    LIGHTENING NIGHT CREAM 
    ethyl macadamiate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51830-020
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ETHYL MACADAMIATE (ETHYL MACADAMIATE) ETHYL MACADAMIATE 1 mg  in 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLYETHYLENE GLYCOL 400  
    GLYCERIN  
    MEDIUM-CHAIN TRIGLYCERIDES  
    ARACHIDYL ALCOHOL  
    METHYL GLUCETH-20  
    DOCOSANOL  
    CAMELLIA KISSII SEED OIL  
    HEXYLDECANOL  
    HEXYLDECYL LAURATE  
    SODIUM POLYACRYLATE (2500000 MW)  
    PROPYLENE GLYCOL  
    CYCLOMETHICONE 5  
    ARACHIDYL GLUCOSIDE  
    PHENOXYETHANOL  
    HYDROGENATED COCONUT OIL  
    SODIUM PYRROLIDONE CARBOXYLATE  
    EDETATE DISODIUM  
    PROPYLPARABEN  
    DIMETHICONOL (100000 CST)  
    METHYLPARABEN  
    MAGNESIUM ASCORBYL PHOSPHATE  
    O-CYMEN-5-OL  
    TROMETHAMINE  
    ETHYLPARABEN  
    GLYCYRRHIZA GLABRA  
    TANGERINE  
    ACRYLIC ACID  
    SUNFLOWER OIL  
    BUTYLENE GLYCOL  
    TOCOPHEROL  
    BAMBUSA VULGARIS TOP  
    ASIAN GINSENG  
    GARDENIA TAITENSIS FLOWER  
    IRIS GERMANICA VAR. FLORENTINA ROOT  
    ASCOPHYLLUM NODOSUM  
    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)
    Close