Label: LIGHTENING SERUM- dicaprylyl ether 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 February 12, 2013

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  • ACTIVE INGREDIENT

    KEY ACTIVE INGREDIENTS

    Seaweed, Licorice Root and Pearl Protein Extracts

  • PURPOSE

    LIGHTENING SERUM

    Coup d'eclat with Seaweed extract and Pearl Protein

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    LIGHTENING SERUM LANGE
    Coup d'eclat Serum is an intensive booster treatment, highly concentrated with whitening Complex. This soft and melting light-gel feel ultra-modern formula will help to: correct skin pigmentation to create a more even appearance, improve skin tone and clarity, creating a more radiant complexion, protect, revitalize, and sublime skin, reinforce action from other LANGE Lightening Products.

  • 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

    20 ml
    0.68 FL. OZ

  • INACTIVE INGREDIENT

    WATER
    PEG-8
    DICAPRYLYL ETHER
    CYCLOPENTASILOXANE
    MANNITOL
    SODIUM POLYACRYLATE
    PROPYLENE GLYCOL
    GLYCERIN
    PHENOXYETHANOL
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER
    SODIUM PCA
    PROPYLPARABEN
    SODIUM GLUCONATE
    DISODIUM EDTA
    METHYLPARABEN
    MAGNESIUM ASCORBYL PHOSPHATE
    o-CYMEN-5-OL
    ETHYLPARABEN
    CITRIC ACID
    SODIUM CITRATE
    TOCOPHEROL
    CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT
    BUTYLENE GLYCOL
    WALTHERIA INDICA LEAF EXTRACT
    GLYCYRRHETINIC ACID
    BAMBUSA VULGARIS LEAF/STEM EXTRACT
    ASCOPHYLLUM NODOSUM EXTRACT
    DEXTRIN
    FERULIC ACID
    GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT
    MALIC ACID
    HYDROLYZED CONCHIOLIN PROTEIN
    TARTARIC ACID
    FREESIA ALBA FLOWER EXTRACT
    GARDENIA TAHITENSIS FLOWER EXTRACT
    HIBISCUS SABDARIFFA FLOWER EXTRACT
    LILIUM CANDIDUM FLOWER EXTRACT
  • PRINCIPAL DISPLAY PANEL

    Label.jpg

  • INGREDIENTS AND APPEARANCE
    LIGHTENING SERUM 
    dicaprylyl ether cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51830-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) (CYCLOMETHICONE 5 - UNII:0THT5PCI0R) CYCLOMETHICONE 50.35 mg  in 20 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    MANNITOL (UNII: 3OWL53L36A)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TANGERINE (UNII: KH3E3096OO)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WALTHERIA INDICA LEAF (UNII: T69OLD6617)  
    ENOXOLONE (UNII: P540XA09DR)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    FERULIC ACID (UNII: AVM951ZWST)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    MALIC ACID (UNII: 817L1N4CKP)  
    TARTARIC ACID (UNII: W4888I119H)  
    FREESIA ALBA FLOWER (UNII: 33X293N6JT)  
    GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51830-022-0220 mg in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/18/2012
    Labeler - Lange SAS (275956105)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lange SAS275956105manufacture(51830-022)