OHUI AGE RECOVERY TRI SHIELD PACT 10 (TITANIUM DIOXIDE, OCTINOXATE) POWDER [LG HOUSEHOLD AND HEALTHCARE, INC.]

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OHUI AGE RECOVERY TRI SHIELD PACT 10 (TITANIUM DIOXIDE, OCTINOXATE) POWDER [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-550-01, 53208-550-02
Set ID 020f4237-396b-4f11-9004-357874ab2e04
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE          4.9%
    OCTINOXATE                  2%


  • 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

    Tri Shiled 20


  • INGREDIENTS AND APPEARANCE
    OHUI AGE RECOVERY TRI SHIELD PACT 10 
    titanium dioxide, octinoxate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-550
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.9 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MICA (UNII: V8A1AW0880)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM MYRISTATE (UNII: Z1917F0578)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WATER (UNII: 059QF0KO0R)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYDATIN (UNII: XM261C37CQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-550-021 in 1 BOX
    1NDC:53208-550-0113 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/11/2011
    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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