NDC | 13537-123-01, 13537-124-01, 13537-125-01, 13537-126-01 |
Set ID | 66979c60-e0a4-4ca0-979b-237873b9ca1b |
Category | HUMAN OTC DRUG LABEL |
Packager | Ventura Corporation Ltd. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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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
- PRINCIPAL DISPLAY PANEL - 27 g Tube Label
- PRINCIPAL DISPLAY PANEL - 27 g Tube Label
- PRINCIPAL DISPLAY PANEL - 27 g Tube Label
- PRINCIPAL DISPLAY PANEL - 27 g Tube Label
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INGREDIENTS AND APPEARANCE
CYZONE CY COVER MAT
octinoxate and titanium dioxide creamProduct 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 creamProduct 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 creamProduct 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 creamProduct 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)