ISAKNOX SUNCARE 365 ADVANCED SUN (ZINC OXIDE, OCTINOXATE, SULFURIC ACID) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

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  • ISAKNOX SUNCARE 365 ADVANCED SUN (ZINC OXIDE, OCTINOXATE, SULFURIC ACID) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]

ISAKNOX SUNCARE 365 ADVANCED SUN (ZINC OXIDE, OCTINOXATE, SULFURIC ACID) CREAM [LG HOUSEHOLD AND HEALTHCARE, INC.]
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NDC 53208-393-01, 53208-393-02
Set ID 29833fff-d574-4e4e-81e8-42ee85dd0cc5
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

    ZINC OXIDE 11.00g/100g

    OCTINOXATE 7.00g/100g

    TITANIUM DIOXIDE 1.00g/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

    365ADVANCEDSUNCREAM

  • INGREDIENTS AND APPEARANCE
    ISAKNOX SUNCARE 365 ADVANCED SUN 
    zinc oxide, octinoxate, sulfuric acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-393
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53208-393-021 in 1 BOX
    1NDC:53208-393-0170 mL in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/30/2010
    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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