Label: CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (BLUSH CURE) - PINK- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (GET WELL PEACH) - PINK- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (PURE OXY .......- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SHINY BROWN) - BROWN- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick
CY BETTER LIPS BALM HUMECTANTE PARA LABIOS CON COLOR FPS 18 (SUN LIGHT) - BEIGE- avobenzone, octisalate, zinc oxide, octinoxate, and oxybenzone lipstick

  • Contains inactivated NDC Code(s)
    NDC Code(s):     13537-169-01, 13537-169-02, 13537-170-03, 13537-170-04, view more
    13537-171-05, 13537-171-06, 13537-172-07, 13537-172-08, 13537-173-09, 13537-173-10, 13537-174-11, 13537-174-12, 13537-175-13, 13537-175-14, 13537-460-15, 13537-460-16, 13537-461-17, 13537-461-18, 13537-462-19, 13537-462-20, 13537-463-21, 13537-463-22, 13537-464-23, 13537-464-24, 13537-465-25, 13537-465-26, 13537-466-27, 13537-466-28
  • Packager: Ventura Corporation LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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

Drug Label Information

Updated January 30, 2014

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Información del medicamento

  • ACTIVE INGREDIENT

    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

    • 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 - 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
  • 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 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)
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