Label: BIELLEE POLLEN HYDRA PURE BRIGHTENING CREAM- dimethicone cream

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

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Drug Label Information

Updated June 21, 2016

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  • ACTIVE INGREDIENT

    DIMETHICONE 0.80%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Temporarily protects chapped or cracked skin
    Prevent and protect from the drying effects of wind and cold weather

  • DOSAGE & ADMINISTRATION

    Apply liberally as needed onto clean facial skin day or night

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    When using this product, keep out of eyes. Rinse with water to remove.

    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    WATER
    BUTYLENE GLYCOL
    POLLEN EXTRACT
    CETYL ETHYLHEXANOATE
    HYDROGENATED POLYDECENE
    GLYCERIN
    CYCLOPENTASILOXANE
    POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE
    CETEARYL ALCOHOL
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE
    NIACINAMIDE
    CYCLOHEXASILOXANE
    GLYCOL PALMITATE
    PHENOXYETHANOL
    GLYCERYL STEARATE
    PEG-100 STEARATE
    PEG-10 DIMETHICONE
    FRAGRANCE
    CYCLOTETRASILOXANE
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
    DIMETHICONOL
    ISOHEXADECANE
    GLYCERYL ACRYLATE/ACRYLIC ACID COPOLYMER
    XANTHAN GUM
    ETHYLHEXYLGLYCERIN
    POLYSORBATE80
    DISODIUM EDTA
    SODIUM HYALURONATE
    NYMPHAEA COERULEA FLOWER EXTRACT

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BIELLEE POLLEN HYDRA PURE BRIGHTENING CREAM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70784-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.4 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BEE POLLEN (UNII: 3729L8MA2C)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCOL PALMITATE (UNII: T80A3T38WE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    NYMPHAEA CAERULEA FLOWER (UNII: S9560USZ74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70784-004-021 in 1 CARTON06/21/2016
    1NDC:70784-004-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/21/2016
    Labeler - NSB CO., LTD. (689846922)
    Registrant - NSB CO., LTD. (689846922)
    Establishment
    NameAddressID/FEIBusiness Operations
    NSB CO., LTD.689846922manufacture(70784-004)
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