Label: SILKY FINISH FLUID- octinoxate lotion

  • 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 18, 2012

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  • Active Ingredient

    Octinoxate 7.5%

  • Description

    A silky lotion with marine-plankton extracts, vitamin F ans sun protection factor (SPF) 12 that oxygenates, regenerates and tones the skin, minimizing the visible signs of aging (wrinkles, dehydration and lack of elasticity).

    15ml. 0.5 FL.oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    SILKYFINISH
  • INGREDIENTS AND APPEARANCE
    SILKY FINISH  FLUID
    octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.125 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-126-021 in 1 BOX
    115 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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