Label: HYALURONIC FILLER SERUM- octinoxate 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 February 20, 2012

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  • Active Ingredient

    Octinoxate 7.5%

  • Description

    Serum with two forms of hyaluronic cid, peptide fillers and marine collagen that generates an instantaneous effect by restoring skin volume and visibly reducing wrinkles. Indicated for rough skin with deep wrinkles.

    30 ml. 1 FL. Oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    HYALURONICFILLER
  • INGREDIENTS AND APPEARANCE
    HYALURONIC FILLER  SERUM
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.25 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-125-021 in 1 BOX
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/01/2011
    Labeler - Zenith Medicosm SL (464239694)
    Registrant - Zenith Medicosm SL (464239694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zenith Medicosm SL464239694manufacture
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