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

CY BETTER LIPS BALM Humectante para Labios con color FPS 18 by

Drug Labeling and Warnings

CY BETTER LIPS BALM Humectante para Labios con color FPS 18 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Información del medicamento

ACTIVE INGREDIENT

Ingredientes activos	Propósito
Avobenzone 0.03%	Protector solar
Octinoxate 7.1%	Protector solar
Octisalate 0.03%	Protector solar
Oxybenzone 2.0%	Protector solar
Zinc oxide1.0%	Protector solar

Uso

• Ayuda a prevenir quemaduras solares

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.

• Sólo para uso externo.

• No usar en piel dañada o lastimada.

• Cuando use este producto mantener alejado de los ojos. Enjuagar con agua para eliminar.

• Detenga su uso y consulte al doctor si sucede enrojecimiento.

• Mantener fuera del alcance de los niños. Si es ingerido obtener ayuda médica o contactar al centro de Control de Envenenamiento inmediatamente

Instrucciones

• Aplicar generosamente y uniformemente 15 minutos antes de la exposición al sol.
• Reaplicar por lo menos cada dos horas.
• Use un protector solar resistente al agua si usted nada o suda.
• Niños menores a 6 meses de edad: Consulte al médico

Otra información

• Proteja el producto del calor excesivo y del sol directo.

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

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - BLUSH CURE - PINK

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - GET WELL PEACH - PINK

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - PURE OXYGEN - BEIGE

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - SAND LIFE - YELLOW

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - CHOCO THERAPY - BROWN

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - INTENSIVE RED - RED

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - DR. ROSE - PINK

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - FUXIA DEFENSE - MAGENTA

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - GRAPE CARE - RED

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - FLASHY KARMIN - RED

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - PINK STAR - PINK

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - LILAC ZIMMER - LILAC

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - SHINY BROWN - BROWN

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

PRINCIPAL DISPLAY PANEL - 4.3 g Tube Label - SUN LIGHT - BEIGE

better lips balm

Humectante para labios
con color FPS 18

cy°

cy°zone

Peso Neto 0.15 oz. (4,3 g)

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

INGREDIENTS AND APPEARANCE

CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18   (BLUSH CURE) - PINK
avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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 lipstick

Product 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)