CYZONE  BE SEXY BS TECH ZINC PYRITHIONE AND SILICONES- pyrithione zinc lotion 
Ventura Corporation Ltd.

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.

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BE Sexy
cy°zone

Drug Facts

Active Ingredient

ZINC PYRITHIONE 0.336 %

Purpose

Antidandruff shampoo

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, SODIUM LAURETH SULFATE, COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, SODIUM CHLORIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, FRAGRANCE, TRIETHANOLAMINE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, GLYCOL DISTEARATE, DICAPRYLYL CARBONATE, HYDROXYPROPYL METHYLCELLULOSE, COCO-GLUCOSIDE, TEA-DODECYLBENZENESULFONATE, CITRIC ACID, GLYCERYL STEARATE, GLYCERYL OLEATE, MAGNESIUM NITRATE, ZINC CHLORIDE, VACCINIUM MYRTILLUS FRUIT/LEAF EXTRACT, SACCHARUM OFFICINARUM EXTRACT (SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT), PEG-4 DISTEARYL ETHER, CI 42090 (BLUE 1), CITRUS AURANTIUM DULCIS FRUIT EXTRACT (CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT), CITRUS LIMON FRUIT EXTRACT (CITRUS LIMON(LEMON) FRUIT EXTRACT ), DISTEARYL ETHER, METHYLCHLOROISOTHIAZOLINONE, ACER SACCHARUM EXTRACT (ACER SACCHARUM (SUGAR MAPLE) EXTRACT), MAGNESIUM CHLORIDE, DYCAPRYLYL ETHER, METHYLISOTHIAZOLINONE, CI 17200 (RED 33)

Questions?

Puerto Rico: 622-3235 (San José)

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

PRINCIPAL DISPLAY PANEL - 375 ml Bottle Label

BE
 Sexy

BS-TECH

SHAMPOO

cy°zone

375 ml e (13.5 fl.oz.)

PRINCIPAL DISPLAY PANEL - 375 ml Bottle Label
CYZONE   BE SEXY BS TECH ZINC PYRITHIONE AND SILICONES
pyrithione zinc lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-400
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)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
COCO GLUCOSIDE (UNII: ICS790225B)  
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GLYCERYL MONOOLEATE (UNII: 4PC054V79P)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
VACCINIUM MYRTILLUS FRUITING TOP (UNII: QT6362QVN8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ORANGE (UNII: 5EVU04N5QU)  
LEMON (UNII: 24RS0A988O)  
DISTEARYL ETHER (UNII: SC6T3MJF8Y)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
ACER SACCHARUM BARK/SAP (UNII: Z120VL0KAC)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-400-01375 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(13537-400)

Revised: 11/2011
Document Id: ff56bc19-d229-4169-94ba-c9d62b1b9831
Set id: ea4af391-6d46-4cb5-8e1b-b73a12aa9e07
Version: 1
Effective Time: 20111129
 
Ventura Corporation Ltd.