Label: SEBORRHEIC PURIFYING- 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 January 21, 2012

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  • Active Ingredient

    Octinoxate 7.5%

  • Description

    A gel-like cream containing biosulfur, hamamelis (witch hazel) and vitamin B that balances the skin's oil levels and combats the bacteria that cause pore blocking, micro cysts and papules. It regulates the hydro lipid mantle and reduces oiliness. Especially indicated for young and oily and/or acned skins.

    50ml. 1.7 fl. Oz


  • Warning

    TOPICAL USE

  • PRINCIPAL DISPLAY PANEL

    SEBORRHEICPURIFYING
  • INGREDIENTS AND APPEARANCE
    SEBORRHEIC  PURIFYING
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TALC (UNII: 7SEV7J4R1U)  
    THYME (UNII: CW657OBU4N)  
    ALOE (UNII: V5VD430YW9)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    SULFUR (UNII: 70FD1KFU70)  
    YEAST (UNII: 3NY3SM6B8U)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    CARBOMER 934 (UNII: Z135WT9208)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42248-108-021 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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