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

  • Category: HUMAN OTC DRUG LABEL

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 21, 2016

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  • ACTIVE INGREDIENT

    DIMETHICONE 1.00%

  • 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
    GLYCERIN
    DIPROPYLENE GLYCOL
    POLLEN EXTRACT
    PENTAERYTHRITYL TETRAISOSTEARATE
    HYDROGENATED POLYDECENE
    MORINDA CITRIFOLIA FRUIT EXTRACT
    BUTYLENE GLYCOL
    CAPRYLIC/CAPRIC TRIGLYCERIDE
    TRIETHYLHEXANOIN
    GLYCERYL STEARATE CITRATE
    NIACINAMIDE
    CETEARYL ALCOHOL
    GLYCERYL STEARATE
    BEHENYL ALCOHOL
    FRAGRANCE
    PEG-100 STEARATE
    PHENOXYETHANOL
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER
    ISOHEXADECANE
    ALLANTOIN
    XANTHAN GUM
    ETHYLHEXYLGLYCERIN
    POLYSORBATE80
    DISODIUM EDTA
    SODIUM HYALURONATE

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BIELLEE POLLEN WHITENING WRINKLE TIME REPAIR CREAM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70784-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BEE POLLEN (UNII: 3729L8MA2C)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    NONI FRUIT (UNII: 7829X3G2X5)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALLANTOIN (UNII: 344S277G0Z)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70784-002-021 in 1 CARTON06/21/2016
    1NDC:70784-002-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/21/2016
    Labeler - NSB CO., LTD. (689846922)
    Registrant - NSB CO., LTD. (689846922)
    Establishment
    NameAddressID/FEIBusiness Operations
    NSB CO., LTD.689846922manufacture(70784-002)
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