Label: LIGHTENING DAY CREAM- dicaprylyl carbonate cream

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

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.

Drug Label Information

Updated July 18, 2012

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  • ACTIVE INGREDIENT

    KEY ACTIVE INGREDIENTS
    Seaweed, Licorice Root and White Tea Extract
  • PURPOSE

    This Whitening Seaweed inhibits melanin synthesis and reduces pigmentation of synthesized melanins with elimination of pigmented scales.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • INDICATIONS & USAGE

    LIGHTENING DAY CREAM LANGE
    A light and moisturizing cream, to help:
    Inhibit skin pigmentation,
    Nourish and moisturize the skin.
  • 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.

  • DOSAGE & ADMINISTRATION

    50 mL
    1.7 FL. OZ
  • INACTIVE INGREDIENT

    WATER (AQUA)
    GLYCERIN
    PEG-8
    DICAPRYLYL CARBONATE
    GLYCERYL STEARATE SE
    ISONONYL ISONONANOATE
    CAMELLIA KISSI SEED OIL
    DIMETHICONE
    POLYACRYLAMIDE
    PHENOXYETHANOL
    PROPYLENE GLYCOL
    CETYL ALCOHOL
    STEARIC ACID
    XANTHAN GUM
    C13-14 ISOPARAFFIN
    SODIUM PCA
    DISODIUM EDTA
    PROPYLPARABEN
    METHYLPARABEN
    LAURETH-7
    MAGNESIUM ASCORBYL PHOSPHATE
    MENTHOXYPROPANEDIOL
    o-CYMEN-5-OL
    GLYCERYL POLYACRYLATE
    GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
    ETHYLPARABEN
    GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT
    BUTYLENE GLYCOL
  • PRINCIPAL DISPLAY PANEL

    image of carton label
    LANGE
    PARIS
    LIGHTENING DAY CREAM
    Morning radiance with Seaweed extracts
    50 ml
    1.7 FL. OZ
  • INGREDIENTS AND APPEARANCE
    LIGHTENING DAY CREAM 
    dicaprylyl carbonate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51830-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4002.5 mg  in 50 mg
    Inactive Ingredients
    Ingredient NameStrength
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    CAMELLIA KISSII SEED OIL (UNII: 96HGN0T99A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    3-((L-MENTHYL)OXY)PROPANE-1,2-DIOL (UNII: KD6TZ2QICH)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51830-019-0450 mg in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/18/2012
    Labeler - LANGE SAS (275956105)
    Registrant - LANGE SAS (275956105)
    Establishment
    NameAddressID/FEIBusiness Operations
    LANGE SAS275956105manufacture(51830-019)