OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE,

OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK (OCTINOXATE, TITANIUM DIOXIDE, OCTISALATE, ENSULIZOLE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE) CREAM [LG HOUSEHOLD AND HEALTHCARE,
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NDC 53208-515-01, 53208-515-02
Set ID adef3aa6-3369-4da2-b7c4-37d80ccdad66
Category HUMAN OTC DRUG LABEL
Packager LG Household and Healthcare, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    OCTINOXATE 7%

    TITANIUM DIOXIDE 6%

    OCTISALATE 4.8%

    ENSULIZOLE 3.9%

    BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE 0.5%

  • 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.

  • PRINCIPAL DISPLAY PANEL

    First Cell Revolution
  • INGREDIENTS AND APPEARANCE
    OHUI THE FIRST CELL REVOLUTION AGE CONTROL SUN BLOCK 
    octinoxate, titanium dioxide, octisalate, ensulizole, bis-ethylhexyloxyphenol methoxyphenyl triazine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-515
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.8 g  in 100 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE3.9 g  in 100 g
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20) DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE0.5 g  in 100 g
    HYDROXYPROLINE (UNII: RMB44WO89X) (HYDROXYPROLINE - UNII:RMB44WO89X) HYDROXYPROLINE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISODODECANE (UNII: A8289P68Y2)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    INULIN (UNII: JOS53KRJ01)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-515-021 in 1 BOX
    1NDC:53208-515-0140 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/06/2011
    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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