Label: LIGHTENING SERUM- cyclomethicone 5 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 02/13

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

  • ACTIVE INGREDIENT

    KEY ACTIVE INGREDIENTS

    Seaweed, Licorice Root and Pearl Protein Extracts

    Close
  • PURPOSE

    LIGHTENING SERUM

    Coup d'eclat with Seaweed extract and Pearl Protein

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Close
  • 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.

    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

    20 ml
    0.68 FL. OZ

    Close
  • 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 Close
  • INGREDIENTS AND APPEARANCE
    LIGHTENING SERUM 
    dicaprylyl ether cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51830-022
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) (CYCLOMETHICONE 5 - UNII:0THT5PCI0R) CYCLOMETHICONE 5 0.35 mg  in 20 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51830-022-02 20 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)
    Establishment
    Name Address ID/FEI Business Operations
    Lange SAS 275956105 manufacture(51830-022)
    Close