Label: WHITENING GLYCOBEST- octinoxate avobenzone titanium oxide cream

  • 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 23, 2012

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  • Active Ingredient

    Octinoxate 7.5%

    Titanium Oxide 25%

    Avobenzone 3%

  • Description

    A cream with high concentrations of Vitamin A, Vitamin C and marine collagen, which are particularly indicated for oily and aging skin.  It combines the regenerating action of Retinol and the bateriostatic action of Vitamin C to fight premature skin aging. Softens and smoothes the skin, reduces wrinkles and gives the skin an even, radiant glow.

    200ml. 6.8Fl.Oz.


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    WHITE
  • INGREDIENTS AND APPEARANCE
    WHITENING  GLYCOBEST
    octinoxate avobenzone titanium oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 mL  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTIC ACID (UNII: 33X04XA5AT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    LEMON JUICE (UNII: AGN709ANTJ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    fytic acid (UNII: 7IGF0S7R8I)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ENZACAMENE (UNII: 8I3XWY40L9)  
    BETULA PUBESCENS BARK (UNII: 3R504894L9)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    iSOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WHITE MULBERRY (UNII: MN25R0HH5A)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    IDEBENONE (UNII: HB6PN45W4J)  
    TRICAPRYLIN (UNII: 6P92858988)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-129-021 in 1 BOX
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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