Cyzone Be Sexy (Pyrithione Zinc) Lotion [Ventura Corporation Ltd.] -

CYZONE BE SEXY (PYRITHIONE ZINC) LOTION [VENTURA CORPORATION LTD.]
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NDC	13537-127-01
Set ID	5cb4c09c-3be7-4744-b9e8-26b7dd29cd45
Category	HUMAN OTC DRUG LABEL
Packager	Ventura Corporation Ltd.
Generic Name
Product Class
Product Number
Application Number	PART358H

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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.)

INGREDIENTS AND APPEARANCE

CYZONE BE SEXY
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-127
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.0036 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13537-127-01	375 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	12/13/2011

Labeler - Ventura Corporation Ltd. (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star, S.A.		880160197	MANUFACTURE(13537-127)

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Medic

CYZONE BE SEXY (PYRITHIONE ZINC) LOTION [VENTURA CORPORATION LTD.]

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