Label: CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (BLUSH CURE) - PINK- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (GET WELL PEACH) - PINK- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (PURE OXY .......- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SHINY BROWN) - BROWN- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SUN LIGHT) - BEIGE- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-169-01, 13537-169-02, 13537-170-03, 13537-170-04, view more13537-171-05, 13537-171-06, 13537-172-07, 13537-172-08, 13537-173-09, 13537-173-10, 13537-174-11, 13537-174-12, 13537-175-13, 13537-175-14, 13537-460-15, 13537-460-16, 13537-461-17, 13537-461-18, 13537-462-19, 13537-462-20, 13537-463-21, 13537-463-22, 13537-464-23, 13537-464-24, 13537-465-25, 13537-465-26, 13537-466-27, 13537-466-28 - Packager: Ventura Corporation LTD
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 30, 2014
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uso
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Advertencias
- Alerta de Cáncer en la piel / envejecimiento de la piel : Pasar tiempo bajo el sol incrementa el riesgo de cáncer y envejecimiento prematuro de la piel. Este producto ha demostrado que únicamente ayuda a prevenir las quemaduras solares pero no previene el cáncer a la piel ni el envejecimiento prematuro de la misma.
- Instrucciones
- Otra información
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Inactive ingredients
Caprylic/capric triglyceride, diisopropyl dimer dilinoleate, ricinus communis (castor) seed oil, octyldodecanol, hydrogenated polyisobutene, polyethylene, euphorbia cerifera (candelilla) wax, beeswax, copernicia cerifera (carnauba) wax, mica, fragrance, dipalmitoyl hydroxyproline, glyceryl isostearate, isostearyl alcohol, glycerin, butyrospermum parkii (shea) butter, bertholletia excelsa seed oil, orbignya oleifera seed oil, tocopheryl acetate, beta-sitosterol, silica dimethyl silylate, sodium saccharin, cetearyl ethylhexanoate, propylparaben, microcrystalline wax, oleyl alcohol, bht, petrolatum, dimethicone, cetyl alcohol, phospholipids, hydrogenated coconut oil, cholesterol, triethoxycaprylylsilane, ozokerite, trimethylsiloxysilicate, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, cetyl ricinoleate, glycosphingolipids.
Puede contener: mica, calcium aluminum borosilicate, titanium dioxide, red 7 lake, iron oxides, red 21 lake, silica, yellow 5 lake , red 40 lake, red 27 lake, talc, carmine, tin oxide, palmitic acid.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - BLUSH CURE - PINK
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - GET WELL PEACH - PINK
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - PURE OXYGEN - BEIGE
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - SAND LIFE - YELLOW
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - CHOCO THERAPY - BROWN
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - INTENSIVE RED - RED
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - DR. ROSE - PINK
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - FUXIA DEFENSE - MAGENTA
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - GRAPE CARE - RED
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - FLASHY KARMIN - RED
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - PINK STAR - PINK
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - LILAC ZIMMER - LILAC
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - SHINY BROWN - BROWN
- PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - SUN LIGHT - BEIGE
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INGREDIENTS AND APPEARANCE
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (BLUSH CURE) - PINK
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-169 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-169-02 1 in 1 BOX 1 NDC:13537-169-01 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (GET WELL PEACH) - PINK
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-170 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-170-04 1 in 1 BOX 1 NDC:13537-170-03 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (PURE OXYGEN) - BEIGE
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-171 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-171-06 1 in 1 BOX 1 NDC:13537-171-05 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SAND LIFE) - YELLOW
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-172 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-172-08 1 in 1 BOX 1 NDC:13537-172-07 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (CHOCO THERAPY) - BROWN
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-173 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-173-10 1 in 1 BOX 1 NDC:13537-173-09 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (INTENSIVE RED) - RED
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-174 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-174-12 1 in 1 BOX 1 NDC:13537-174-11 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (DR. ROSE) - PINK
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-175 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-175-14 1 in 1 BOX 1 NDC:13537-175-13 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (FUXIA DEFENSE) - MAGENTA
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-460 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-460-16 1 in 1 BOX 1 NDC:13537-460-15 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (GRAPE CARE) - RED
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-461 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-461-18 1 in 1 BOX 1 NDC:13537-461-17 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (FLASHY KARMIN) - RED
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-462 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-462-20 1 in 1 BOX 1 NDC:13537-462-19 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (PINK STAR) - PINK
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-463 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-463-22 1 in 1 BOX 1 NDC:13537-463-21 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (LILAC ZIMMER) - LILAC
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-464 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-464-24 1 in 1 BOX 1 NDC:13537-464-23 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SHINY BROWN) - BROWN
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-465 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-465-26 1 in 1 BOX 1 NDC:13537-465-25 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SUN LIGHT) - BEIGE
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-466 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.0003 g in 1 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.0003 g in 1 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.01 g in 1 g Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.071 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR) CASTOR OIL (UNII: D5340Y2I9G) OCTYLDODECANOL (UNII: 461N1O614Y) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CARNAUBA WAX (UNII: R12CBM0EIZ) MICA (UNII: V8A1AW0880) DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) BRAZIL NUT OIL (UNII: 0G89T29HO6) BABASSU OIL (UNII: 8QSB4M5477) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) .BETA.-SITOSTEROL (UNII: S347WMO6M4) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) SACCHARIN SODIUM (UNII: SB8ZUX40TY) CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OLEYL ALCOHOL (UNII: 172F2WN8DV) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PETROLATUM (UNII: 4T6H12BN9U) DIMETHICONE (UNII: 92RU3N3Y1O) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM) CHOLESTEROL (UNII: 97C5T2UQ7J) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CETYL RICINOLEATE (UNII: 1P677500YD) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 7 (UNII: ECW0LZ41X8) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C RED NO. 21 (UNII: 08744Z6JNY) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) FD&C RED NO. 40 (UNII: WZB9127XOA) D&C RED NO. 27 (UNII: 2LRS185U6K) TALC (UNII: 7SEV7J4R1U) STANNIC OXIDE (UNII: KM7N50LOS6) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-466-28 1 in 1 BOX 1 NDC:13537-466-27 4.3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 01/27/2014 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-169, 13537-170, 13537-171, 13537-172, 13537-173, 13537-174, 13537-175, 13537-460, 13537-461, 13537-462, 13537-463, 13537-464, 13537-465, 13537-466)