ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (MARRON HAVANA) - BROWN- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (NATURAL DUNE) - PINK- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (MARRON FANATIC) - RED- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (ROJO FIESTA) - RED- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (MARRON BAMBU) - BROWN- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (FUCSIA DELIRIO) - PINK- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (ROJO PASION) - RED- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (FUCSIA SUBLIME) - PINK- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (ROSA FIORELLE) - PINK- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (NARANJA OBSESION) - ORANGE- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (BORGONA SWEET) - PINK- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (VINO DESEO) - PURPLE- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20  (FUCSIA TENTACION) - PINK- octinoxate lipstick 
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20- octinoxate 
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.

----------

ÉSIKA PRO ADVANCE LASTING LIPSTICK Long-lasting and comfort lipstick SPF 20

Drug Facts

Active Ingredients

OCTINOXATE: 7.00%

Purpose

Sunscreen

Uses

Warnings

  • Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

  • Do not use on damaged or broken skin.

  • When using this product keep out of eyes.Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, POLYMETHYL METHACRYLATE, TRIDECYL STEARATE, POLYGLYCERYL-3 DIISOSTEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, SYNTHETIC BEESWAX, TOCOPHERYL ACETATE, PHENOXYETHANOL, CERAMIDE 3, CAPRYLYL GLYCOL, CHLORPHENESIN, FRAGRANCE.

MAY CONTAIN :

MICA, MANGANESE VIOLET, TITANIUM DIOXIDE, BISMUTH OXYCHLORIDE, IRON OXIDES, RED 21 LAKE, RED 27 LAKE, YELLOW 5 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE.

Dist. by Ventura Corp,
Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON HAVANA) - BROWN

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON HAVANA) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NATURAL DUNE) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NATURAL DUNE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON FANATIC) - RED

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON FANATIC) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO FIESTA) - RED

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO FIESTA) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON BAMBU) - BROWN

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON BAMBU) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DELIRIO) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DELIRIO) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO PASION) - RED

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO PASION) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SUBLIME) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SUBLIME) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA FIORELLE) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA FIORELLE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA OBSESION) - ORANGE

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA OBSESION) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGOÑA SWEET) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGOÑA SWEET) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VINO DESEO) - PURPLE

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VINO DESEO) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA TENTACION) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA TENTACION) - PINK

PRINCIPAL DISPLAY PANEL - Kit Carton

ADVANCE
LASTING LIPSTICK
LONG-LASTING AND COMFORT LIPSTICK SPF 20

ésika
PRO

Net Weight 0.24 oz. e (6.8 g.)

PRINCIPAL DISPLAY PANEL - Kit Carton
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (MARRON HAVANA) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-638
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-638-021 in 1 BOX
1NDC:13537-638-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (NATURAL DUNE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-639
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-639-041 in 1 BOX
1NDC:13537-639-034 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (MARRON FANATIC) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-640
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-640-061 in 1 BOX
1NDC:13537-640-054 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (ROJO FIESTA) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-642
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-642-081 in 1 BOX
1NDC:13537-642-074 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (MARRON BAMBU) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-643
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-643-101 in 1 BOX
1NDC:13537-643-094 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (FUCSIA DELIRIO) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-644
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-644-121 in 1 BOX
1NDC:13537-644-114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (ROJO PASION) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-645
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-645-141 in 1 BOX
1NDC:13537-645-134 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (FUCSIA SUBLIME) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-646
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-646-161 in 1 BOX
1NDC:13537-646-154 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (ROSA FIORELLE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-647
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-647-181 in 1 BOX
1NDC:13537-647-174 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (NARANJA OBSESION) - ORANGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-648
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-648-201 in 1 BOX
1NDC:13537-648-194 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (BORGONA SWEET) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-649
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-649-221 in 1 BOX
1NDC:13537-649-214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (VINO DESEO) - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-650-241 in 1 BOX
1NDC:13537-650-234 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (FUCSIA TENTACION) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-651
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-651-261 in 1 BOX
1NDC:13537-651-254 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 
octinoxate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-688
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-688-282 in 1 CARTON
1NDC:13537-688-271 in 1 TUBE
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 6.8 g
Part 21 TUBE 6.8 g
Part 31 TUBE 6.8 g
Part 41 TUBE 6.8 g
Part 51 TUBE 6.8 g
Part 61 TUBE 6.8 g
Part 71 TUBE 6.8 g
Part 81 TUBE 6.8 g
Part 91 TUBE 6.8 g
Part 101 TUBE 6.8 g
Part 111 TUBE 6.8 g
Part 121 TUBE 6.8 g
Part 1 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (MARRON HAVANA) - BROWN
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 2 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (NATURAL DUNE) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 3 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (MARRON FANATIC) - RED
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 4 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (ROJO FIESTA) - RED
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 5 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (MARRON BAMBU) - BROWN
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 6 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (FUCSIA DELIRIO) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 7 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (ROJO PASION) - RED
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 8 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (FUCSIA SUBLIME) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 9 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (ROSA FIORELLE) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 10 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (BORGONA SWEET) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 11 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (VINO DESEO) - PURPLE
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Part 12 of 12
ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20   (FUCSIA TENTACION) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CERAMIDE 3 (UNII: 4370DF050B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
MICA (UNII: V8A1AW0880)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/17/2015
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-638, 13537-639, 13537-640, 13537-642, 13537-643, 13537-644, 13537-645, 13537-646, 13537-647, 13537-648, 13537-649, 13537-650, 13537-651, 13537-688)

Revised: 4/2015
Document Id: a18be7ad-727e-4429-a843-9924fd65f743
Set id: e4036c28-26fc-4757-bc5d-b640aca46509
Version: 1
Effective Time: 20150417
 
Ventura Corporation LTD