Label: ISAKNOX AGELESS SERUM BLEMISH BALM - titanium dioxide, octyltriethoxysilane, aluminum hydroxide, octinoxate, atractyloides japonica root oil cream

  • NDC Code(s): 53208-475-01, 53208-475-02
  • Packager: LG Household and Healthcare, Inc.
  • 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 May 15, 2012

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  • Active Ingredients

    Enter section text here

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  • Warning and Precautions

    For external use only.

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  • 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.

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  • WHEN USING

    Keep out of eyes. Rinse with water to remove.

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  • Package Label

    Isaknox

    Ageless

    Blemish Balm

    Ageless BB Cream

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  • INGREDIENTS AND APPEARANCE
    ISAKNOX AGELESS SERUM BLEMISH BALM 
    titanium dioxide, octyltriethoxysilane, aluminum hydroxide, octinoxate, atractyloides japonica root oil cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-475
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5.76 mL  in 100 mL
    OCTYLTRIETHOXYSILANE (UNII: LDC331P08E) (OCTYLTRIETHOXYSILANE - UNII:LDC331P08E) OCTYLTRIETHOXYSILANE 0.12 mL  in 100 mL
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) ALUMINUM HYDROXIDE 0.12 mL  in 100 mL
    ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU) (ATRACTYLODES JAPONICA ROOT - UNII:58N5X5H9XU) ATRACTYLODES JAPONICA ROOT 0.05 mL  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53208-475-02 1 in 1 BOX
    1 NDC:53208-475-01 50 mL in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 08/24/2010
    Labeler - LG Household and Healthcare, Inc. (688276187)
    Registrant - LG Household and Healthcare, Inc. (688276187)
    Establishment
    Name Address ID/FEI Business Operations
    LG Household and Healthcare, Inc. 688276187 manufacture
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