Label: BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR SERUM- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 June 22, 2016

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

  • ACTIVE INGREDIENT

    DIMETHICONE 2.55%

  • 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
    PROPANEDIOL
    BUTYLENE GLYCOL
    POLLEN EXTRACT
    MACADAMIA TERNIFOLIA SEED OIL
    MORINDA CITRIFOLIA FRUIT EXTRACT
    CAPRYLIC/CAPRIC TRIGLYCERIDE
    NIACINAMIDE
    C14-22 ALCOHOLS
    PENTAERYTHRITYL TETRAETHYLHEXANOATE
    GLYCERIN
    BUTYROSPERMUM PARKII (SHEA BUTTER)
    GLYCERYL STEARATE
    FRAGRANCE
    CYCLOPENTASILOXANE
    PHENOXYETHANOL
    PEG-10 DIMETHICONE
    PEG-4 OLIVATE
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
    C12-20 ALKYL GLUCOSIDE
    PEG-100 STEARATE
    CYCLOHEXASILOXANE
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
    HYDROGENATED LECITHIN
    XANTHAN GUM
    TREHALOSE
    ISOHEXADECANE
    ETHYLHEXYLGLYCERIN
    DISODIUM EDTA
    POLYSORBATE80
    SODIUM HYALURONATE
    GLYCERYL CAPRYLATE

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR SERUM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70784-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.02 mg  in 40 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BEE POLLEN (UNII: 3729L8MA2C)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    NONI FRUIT (UNII: 7829X3G2X5)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PEG-4 OLEATE (UNII: 9QL37EC4J7)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TREHALOSE (UNII: B8WCK70T7I)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70784-003-021 in 1 CARTON06/22/2016
    1NDC:70784-003-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/22/2016
    Labeler - NSB CO., LTD. (689846922)
    Registrant - NSB CO., LTD. (689846922)
    Establishment
    NameAddressID/FEIBusiness Operations
    NSB CO., LTD.689846922manufacture(70784-003)