Label: TONYMOLY PANDAS DREAM BRIGHTENING EYE BASE- 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 February 10, 2016

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

  • Active Ingredients

    Dimethicone 12.10%, Glycerin 0.0015%, Lanolin 2.00%, Titanium Dioxide 1.96%

  • Purpose

    Skin Protectant

  • Use

    This portable Stick-type Eye Base brightens up areas around the eyes with its speedy coverage.

  • Caution

    For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

  • Keep out of reach of children

    Keep out of reach of children.

  • Directions

    Apply it around the eyes where you have dark circles and blemishes and pat lightly to absorb.

  • Inactive Ingredients

    Caprylic/Capric Triglyceride, Isopropyl Myristate, Methyl Methacrylate Crosspolymer, Mica, Euphorbia Cerifera (Candelilla) Wax, Dimethicone/Vinyl Dimethicone, Crosspolymer, Microcrystalline Wax, Sorbitan Olivate, Ceresin, Sorbitan Sesquioleate, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Methicone, Tropolone, Triethoxycaprylylsilane, Pearl Extract, Water, Bambusa Vulgaris Shoot Extract, Bambusa Vulgaris Sap Extract, Steareth-20, N-Hydroxysuccinimide, Chlorhexidine Digluconate, Potassium Sorbate, Chrysin, Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7

  • Principal Display Panel

    product

  • INGREDIENTS AND APPEARANCE
    TONYMOLY PANDAS DREAM BRIGHTENING EYE BASE 
    other skin care preparations cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.1764 g  in 9 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN0.18 g  in 9 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.000135 g  in 9 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.089 g  in 9 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CHRYSIN (UNII: 3CN01F5ZJ5)  
    CERESIN (UNII: Q1LS2UJO3A)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    TROPOLONE (UNII: 7L6DL16P1T)  
    MICA (UNII: V8A1AW0880)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    BAMBUSA VULGARIS SAP (UNII: 26W4035XBO)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    N-HYDROXYSUCCINIMIDE (UNII: MJE3791M4T)  
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-150-011 in 1 CELLO PACK01/19/2016
    19 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/14/2016
    Labeler - Tonymoly Co., Ltd. (688216798)
    Registrant - Tonymoly Co., Ltd. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANACOS CO., LTD.690177857manufacture(59078-150)