CYZONE CY COVER MAT- octinoxate and titanium dioxide cream

CYZONE by

Drug Labeling and Warnings

CYZONE by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation Ltd., Bel Star, S. A.(Colombia), Yobel Supply Chain Management (Peru). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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))

SPL UNCLASSIFIED SECTION

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

cover mat

cy°

cy°zone

27 g e (.95 oz.)

PRINCIPAL DISPLAY PANEL - 27 g Tube Label

cover mat

cy°

cy°zone

27 g e (.95 oz.)

PRINCIPAL DISPLAY PANEL - 27 g Tube Label

cover mat

cy°

cy°zone

27 g e (.95 oz.)

INGREDIENTS AND APPEARANCE

CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.008 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (Sun Beige - Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-123-01	1 in 1 BAG
1		27 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/13/2011

CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-124
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.008 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (Over Sand - Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-124-01	1 in 1 BAG
1		27 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/13/2011

CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.008 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (Midd Confidential - Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-125-01	1 in 1 BAG
1		27 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/13/2011

CYZONE   CY COVER MAT
octinoxate and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-126
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.06 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	0.008 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN (Secret Light - Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-126-01	1 in 1 BAG
1		27 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/13/2011

Labeler - Ventura Corporation Ltd. (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star, S. A.(Colombia)		880160197	MANUFACTURE(13537-123, 13537-124, 13537-125, 13537-126)

Establishment
Name	Address	ID/FEI	Business Operations
Yobel Supply Chain Management (Peru)		934116930	MANUFACTURE(13537-123, 13537-124, 13537-125, 13537-126)