Label: LIGHTENING DAY CREAM- polyethylene glycol 400 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, Licorice Root and White Tea Extract Close
  • PURPOSE

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

    Keep out of reach of children.
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  • INDICATIONS & USAGE

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

    image of carton label
    LANGE
    PARIS
    LIGHTENING DAY CREAM
    Morning radiance with Seaweed extracts
    50 ml
    1.7 FL. OZ Close
  • INGREDIENTS AND APPEARANCE
    LIGHTENING DAY CREAM 
    dicaprylyl carbonate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-019
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 2.5 mg  in 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51830-019-04 50 mg in 1 CONTAINER
    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(51830-019)
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