Label: CYZONE BE SEXY- pyrithione zinc lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 29, 2011

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    ZINC PYRITHIONE 0.336 %

  • Purpose

    Antidandruff conditioner

  • Uses

    Reduces the symptoms of dandruff

  • Warnings

    For external use only

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    If condition worsens or does not improve after regular use of this product as directed, consult a doctor

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For best results use at least twice a week or as directed by a doctor.

  • Inactive ingredients

    WATER, CETEARYL ALCOHOL, DIMETHICONE, STEARAMIDOPROPYL DIMETHYLAMINE, CYCLOPENTASILOXANE, CETRIMONIUM CHLORIDE , DIMETHICONOL, CETYL ALCOHOL, CYCLOHEXASILOXANE, CITRIC ACID, FRAGRANCE, TEA-DODECYLBENZENESULFONATE, CI 77891 (TITANIUM DIOXIDE ), MAGNESIUM NITRATE, ZINC CHLORIDE, GLYCERIN, VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT, GLYCOL DISTEARATE, SACCHARUM OFFICINARUM EXTRACT (SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT), PEG-4 DISTEARIL ETER, COCO-GLUCOSIDE, SODIUM LAURETH SULFATE, PANTHENOL, HYDROLYZED WHEAT PROTEIN, CITRUS AURANTIUM DULCIS FRUIT EXTRACT (CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT), CITRUS LIMON FRUIT EXTRACT (CITRUS LIMON(LEMON) FRUIT EXTRACT ), DISTEARYL ETHER, METHYLCHLOROISOTHIAZOLINONE, HYDROLYZED RICE PROTEIN, CARBOCYSTEINE, GLYCERYL STEARATE, ACER SACCHARUM EXTRACT (ACER SACCHARUM (SUGAR MAPLE) EXTRACT), GLYCERYL OLEATE, POLYQUATERNIUM-10, MAGNESIUM CHLORIDE, DYCAPRYLYL ETHER, PEG-70 MANGO GLYCERIDES, METHYLISOTHIAZOLINONE

  • Questions?

    Puerto Rico: 622-3235 (San José)

  • SPL UNCLASSIFIED SECTION

    Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924.

  • PRINCIPAL DISPLAY PANEL - 375 ml Bottle Label

    BE
    Sexy

    BS-TECH

    Zinc Pyrithione
    & silicones

    ANTI-DANDRUFF CONDITIONER

    cy°zone

    375 ml e (12.67 fl.oz.)

    Principal Display Panel - 375 ml Bottle Label

  • INGREDIENTS AND APPEARANCE
    CYZONE   BE SEXY
    pyrithione zinc lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-127
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc0.0036 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    VACCINIUM MYRTILLUS FRUITING TOP (UNII: QT6362QVN8)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ORANGE (UNII: 5EVU04N5QU)  
    LEMON (UNII: 24RS0A988O)  
    DISTEARYL ETHER (UNII: SC6T3MJF8Y)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    CARBOCYSTEINE (UNII: 740J2QX53R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
    ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-127-01375 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/13/2011
    Labeler - Ventura Corporation Ltd. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star, S.A.880160197MANUFACTURE(13537-127)