Label: OHUI AGE RECOVERY TRI SHIELD PACT 10- 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 December 8, 2011

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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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