Label: CATHYCAT ESSENCE SUN BB- titanium dioxide, octinoxate, zinc oxide, amiloxate liquid

  • Category: HUMAN OTC DRUG LABEL

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 May 16, 2012

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  • ACTIVE INGREDIENT

    Titanium Dioxide 13.76%

    OCTINOXATE 7%

    Zinc Oxide 3.92%

    AMILOXATE 1%


  • 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

    Essence BB

  • INGREDIENTS AND APPEARANCE
    CATHYCAT ESSENCE SUN BB 
    titanium dioxide, octinoxate, zinc oxide, amiloxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-528
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide13.76176 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide3.92 mL  in 100 mL
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Dipropylene Glycol (UNII: E107L85C40)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    METHYL METHACRYLATE (UNII: 196OC77688)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    Sorbitan (UNII: 6O92ICV9RU)  
    Hectorite (UNII: 08X4KI73EZ)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Trihydroxystearin (UNII: 06YD7896S3)  
    Methylparaben (UNII: A2I8C7HI9T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Iron (UNII: E1UOL152H7)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Ethylparaben (UNII: 14255EXE39)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-528-021 in 1 BOX
    1NDC:53208-528-0150 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/15/2011
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    NameAddressID/FEIBusiness Operations
    LG Household and Healthcare, Inc.688276187manufacture