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 OXYGEN) - BEIGE- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (SAND LIFE) - YELLOW- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (CHOCO THERAPY) - BROWN- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (INTENSIVE RED) - RED- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (DR. ROSE) - PINK- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (FUXIA DEFENSE) - MAGENTA- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (GRAPE CARE) - RED- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (FLASHY KARMIN) - RED- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (PINK STAR) - PINK- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick 
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18  (LILAC ZIMMER) - LILAC- 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 
Ventura Corporation LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

Información del medicamento

Ingredientes activosPropósito
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

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

Otra información

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.

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 - BLUSH CURE - PINK

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 - GET WELL PEACH - PINK

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 - PURE OXYGEN - BEIGE

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 - SAND LIFE - YELLOW

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 - CHOCO THERAPY - BROWN

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 - INTENSIVE RED - RED

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 - DR. ROSE - PINK

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 - FUXIA DEFENSE - MAGENTA

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 - GRAPE CARE - RED

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 - FLASHY KARMIN - RED

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 - PINK STAR - PINK

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 - LILAC ZIMMER - LILAC

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 - SHINY BROWN - BROWN

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

Principal Display Panel - 4.3 g Tube Label - SUN LIGHT - BEIGE
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-169-021 in 1 BOX
1NDC:13537-169-014.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-170-041 in 1 BOX
1NDC:13537-170-034.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-171
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-171-061 in 1 BOX
1NDC:13537-171-054.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-172
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-172-081 in 1 BOX
1NDC:13537-172-074.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-173
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-173-101 in 1 BOX
1NDC:13537-173-094.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-174
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-174-121 in 1 BOX
1NDC:13537-174-114.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-175-141 in 1 BOX
1NDC:13537-175-134.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-460
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-460-161 in 1 BOX
1NDC:13537-460-154.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-461
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-461-181 in 1 BOX
1NDC:13537-461-174.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-462
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-462-201 in 1 BOX
1NDC:13537-462-194.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-463
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-463-221 in 1 BOX
1NDC:13537-463-214.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-464
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-464-241 in 1 BOX
1NDC:13537-464-234.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-465
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-465-261 in 1 BOX
1NDC:13537-465-254.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
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 TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-466
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.0003 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.0003 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.01 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.071 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-466-281 in 1 BOX
1NDC:13537-466-274.3 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35201/27/2014
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(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)

Revised: 1/2014
Document Id: 56761eca-a1fc-417e-8fd1-4929b9d81cf7
Set id: 48479f1b-40e8-43cf-acdb-c371b1194253
Version: 1
Effective Time: 20140130
 
Ventura Corporation LTD