Label: SOORHYEHAN ONBIT TWO WAY CAKE 23- titanium dioxide, octinoxate powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 25, 2011

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  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE 5.88g/100g

    OCTINOXATE 4g/100g

  • WARNINGS AND PRECAUTIONS

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use if a rash or irritation develops and lasts.

  • PRINCIPAL DISPLAY PANEL


    ONBIT TWO WAY CAKE 23



    ONBIT TWO WAY CAKE 23

  • INGREDIENTS AND APPEARANCE
    SOORHYEHAN ONBIT TWO WAY CAKE 23 
    titanium dioxide, octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-545
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.88 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    MICA (UNII: V8A1AW0880)  
    TRICHOSANTHES KIRILOWII ROOT (UNII: V409XGE0TS)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    CAROB (UNII: 5MG5Z946UO)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    SCHISANDRA CHINENSIS FRUIT (UNII: ABS794681C)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    HONEY (UNII: Y9H1V576FH)  
    BAMBUSA VULGARIS SAP (UNII: 26W4035XBO)  
    PATCHOULI OIL (UNII: F3IN55X5PO)  
    PRUNUS ARMENIACA SEED (UNII: 75356789IW)  
    LIGUSTICUM TENUISSIMUM ROOT (UNII: 2O0H84E074)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-545-021 in 1 BOX
    1NDC:53208-545-0114 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/25/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture
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