CYZONE  CY COVER MAT- octinoxate and titanium dioxide cream 
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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cy°zone
cover mat

Drug Facts

Active Ingredients

OCTINOXATE 6.0 %, TITANIUM DIOXIDE 0.8 %

Purpose

sunscreen

Uses

*
Helps prevent sunburn
*
Higher SPF gives more sunburn protection.
*
Provides moderate protection against sunburn

Warnings

For external only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions

*
Apply generously and evently before sun exposure and as needed

Inactive ingredients

WATER, CYCLOPENTASILOXANE, SILICA, CYCLOHEXASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, HEXYL LAURATE, TRIMETHYLSILOXYSILICATE, GLYCERIN, SODIUM CHLORIDE, DISTEARDIMONIUM HECTORITE, BAMBUSA ARUNDINACEA STEM POWDER, PEG/PPG-19/19 DIMETHICONE, DIAZOLIDINYL UREA, METHYLPARABEN, PROPYLENE CARBONATE, PROPYLPARABEN, SILICA DIMETHYL SILYLATE, LYCOPODIUM CLAVATUM EXINE, TOCOPHERYL ACETATE, ALUMINA, TRIETHOXYCAPRYLYLSILANE, BHA, BHT, IMPERATA CYLINDRICA ROOT EXTRACT, METHICONE. MAY CONTAIN: CI 77492 (IRON OXIDES), CI 77491 (IRON OXIDES), CI 77499 (IRON OXIDES))

P.R.:Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 27 g Tube Label

cover mat

cy°

cy°zone

27 g e (.95 oz.)

Principal Display Panel - 27 g Tube Label

PRINCIPAL DISPLAY PANEL - 27 g Tube Label

cover mat

cy°

cy°zone

27 g e (.95 oz.)

Principal Display Panel - 27 g Tube Label

PRINCIPAL DISPLAY PANEL - 27 g Tube Label

cover mat

cy°

cy°zone

27 g e (.95 oz.)

Principal Display Panel - 27 g Tube Label

PRINCIPAL DISPLAY PANEL - 27 g Tube Label

cover mat

cy°

cy°zone

27 g e (.95 oz.)

Principal Display Panel - 27 g Tube Label
CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.008 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Sun Beige - Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-123-011 in 1 BAG
127 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/13/2011
CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.008 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Over Sand - Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-124-011 in 1 BAG
127 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/13/2011
CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.008 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Midd Confidential - Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-125-011 in 1 BAG
127 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/13/2011
CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.008 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Secret Light - Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-126-011 in 1 BAG
127 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/13/2011
Labeler - Ventura Corporation Ltd. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star, S. A.(Colombia)880160197MANUFACTURE(13537-123, 13537-124, 13537-125, 13537-126)
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management (Peru)934116930MANUFACTURE(13537-123, 13537-124, 13537-125, 13537-126)

Revised: 11/2011
Document Id: c789fd9b-5e71-480f-bb54-8bd33bef1c4b
Set id: 66979c60-e0a4-4ca0-979b-237873b9ca1b
Version: 1
Effective Time: 20111129
 
Ventura Corporation Ltd.