ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - BROWN- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - PURPLE- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE- octinoxate lipstick 
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate 
Ventura Corporation LTD

----------

ESIKA PRO HD COLOR HIGH DEFINITION COLOR LIPSTICK SPF 20

Drug Facts

Active Ingredients

Octinoxate 6.8 %

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.

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, notskin cancer or early skin aging.

  • For external use only.

  • Do not useon damaged or broken skin.

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

  • Stop use and ask a doctor ifrash occurs.

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

Directions

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: Ask a doctor

Other information

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

DIISOPROPYL DIMER DILINOLEATE, OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, TRIDECYL TRIMELLITATE, CASTOR ISOSTEARATE BEESWAX SUCCINATE, POLYGLYCERYL-3 DIISOSTEARATE, ISOPROPYL LANOLATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICA, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHENOXYETHANOL, BETA-SITOSTEROL, PHENYL TRIMETHICONE, SILICA, SILICA SILYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, FRAGRANCE, CAPRYLYL GLYCOL, DIMETHICONE, CHLORPHENESIN, CERAMIDE 3, TOCOPHERYL ACETATE, OLEYL ALCOHOL, TRIMETHYLSILOXYSILICATE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, DIOLEYL TOCOPHERYL METHYLSILANOL. May Contain: TITANIUM DIOXIDE, MICA, IRON OXIDES, RED 30 LAKE, RED 7 LAKE, YELLOW 5 LAKE, RED 27 LAKE, TALC, CALCIUM ALUMINUM BOROSILICATE, CARMINE, TIN OXIDE.

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD PIMIENTA CALIENTE) - BROWN

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD PIMIENTA CALIENTE) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD VINO CAUTIVANTE) - BROWN

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD VINO CAUTIVANTE) - BROWN

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

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD ROSA VIVA) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CORAL ENSUENO) - RED

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD CORAL ENSUENO) - RED

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

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD ROJO GLAM) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CAFE HABANO) - BROWN

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD CAFE HABANO) - BROWN

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

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD FUCSIA VIBRANTE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD MELON INTENSE) - PINK

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD MELON INTENSE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROSADO CHIC) - PINK

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD ROSADO CHIC) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CIRUELA GLAM) - RED

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD CIRUELA GLAM) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD FRAMBUESA ENCANTO) - PURPLE

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD FRAMBUESA ENCANTO) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD MAGENTA SWEET) - PURPLE

HD COLOR
High Definition Color
LIPSTICK SPF 20

Net Weight 0.14 oz e(4 g)

ésika
PRO

Principal Display Panel - 4 g Tube Box (HD MAGENTA SWEET) - PURPLE

PRINCIPAL DISPLAY PANEL - Kit Carton

HD COLOR
HIGH DEFINITION COLOR LIPSTICK
SPF 20

ésika
PRO

Net Weight
0.275 oz. e(7.8 g)

Principal Display Panel - Kit Carton
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-577
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-577-021 in 1 BOX04/17/201512/31/2021
1NDC:13537-577-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD VINO CAUTIVANTE) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-578
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-578-041 in 1 BOX04/17/201512/31/2021
1NDC:13537-578-034 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSA VIVA) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-579
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-579-061 in 1 BOX04/17/201512/31/2021
1NDC:13537-579-054 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CORAL ENSUENO) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-580
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-580-081 in 1 BOX04/17/201512/31/2021
1NDC:13537-580-074 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROJO GLAM) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-581
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-581-101 in 1 BOX04/17/201512/31/2021
1NDC:13537-581-094 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CAFE HABANO) - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-582
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-582-121 in 1 BOX04/17/201512/31/2021
1NDC:13537-582-114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-583
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-583-141 in 1 BOX04/17/201512/31/2021
1NDC:13537-583-134 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MELON INTENSE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-584
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-584-161 in 1 BOX04/17/201512/31/2021
1NDC:13537-584-154 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSADO CHIC) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-585
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-585-181 in 1 BOX04/17/201512/31/2021
1NDC:13537-585-174 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CIRUELA GLAM) - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-586
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-586-201 in 1 BOX04/17/201512/31/2021
1NDC:13537-586-194 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FRAMBUESA ENCANTO) - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-587
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-587-221 in 1 BOX04/17/201512/31/2021
1NDC:13537-587-214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MAGENTA SWEET) - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-588
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-588-241 in 1 BOX04/17/201512/31/2021
1NDC:13537-588-234 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 
octinoxate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-589
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-589-282 in 1 BOX04/17/201512/31/2021
1NDC:13537-589-271 in 1 TUBE; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 4 g
Part 21 TUBE 4 g
Part 31 TUBE 4 g
Part 41 TUBE 4 g
Part 51 TUBE 4 g
Part 61 TUBE 4 g
Part 71 TUBE 4 g
Part 81 TUBE 4 g
Part 91 TUBE 4 g
Part 101 TUBE 4 g
Part 111 TUBE 4 g
Part 121 TUBE 4 g
Part 1 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 2 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD VINO CAUTIVANTE) - BROWN
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 3 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSA VIVA) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 4 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CORAL ENSUENO) - RED
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 5 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROJO GLAM) - RED
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 6 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CAFE HABANO) - BROWN
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 7 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 8 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MELON INTENSE) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 9 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSADO CHIC) - PINK
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 10 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CIRUELA GLAM) - RED
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 11 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FRAMBUESA ENCANTO) - PURPLE
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Part 12 of 12
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MAGENTA SWEET) - PURPLE
octinoxate lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.068 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE 3 (UNII: 4370DF050B)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TALC (UNII: 7SEV7J4R1U)  
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02004/17/201512/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-577, 13537-578, 13537-579, 13537-580, 13537-581, 13537-582, 13537-583, 13537-584, 13537-585, 13537-586, 13537-587, 13537-588, 13537-589)

Revised: 2/2025
Document Id: 2f379eb4-5838-407c-e063-6294a90a857e
Set id: f92b49ec-af7b-440f-a69b-d71b9f6dd5bf
Version: 2
Effective Time: 20250228
 
Ventura Corporation LTD