ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 VINO CAUTIVANTE - PURPLE- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 PIMIENTA CALIENTE - RED- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO GLAM - RED- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO PASION - RED- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 VINO DESEO - PURPLE- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA TENTACION - PINK- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA DELIRIO - PINK- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA VIBRANTE - PINK- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROSA VIVA - PINK- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 CORAL ENSUENO - RED- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON BAMBU - BROWN- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROSA FIORELLE - PINK- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NATURAL DUNE - BEIGE- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO FIESTA - RED- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE CREAM - BEIGE- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE MOCCHA - BEIGE- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 FUCSIA SUBLIME - PINK- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON HAVANA - BROWN- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON FANATIC - BROWN- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE ROSE- BEIGE- octinoxate lipstick 
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20- octinoxate 
Ventura Corporation LTD

----------

Ésika PRO HD LONGWEAR LONG-LASTING 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, TRIDECYL TRIMELLITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, OCTYLDODECANOL, CASTOR ISOSTEARATE BEESWAX SUCCINATE, ISOPROPYL LANOLATE, POLYGLYCERYL-3 DIISOSTEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, MICA, ISODODECANE, POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, SILICA, SILICA SILYLATE, HEXYL LAURATE, METHYLPROPANEDIOL, FRAGRANCE, CAPRYLYL GLYCOL, CHLORPHENESIN, CERAMIDE 3, SILANEDIOL SALICYLATE, TOCOPHERYL ACETATE, OLEYL ALCOHOL, DIMETHICONE, TROMETHAMINE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIOLEYL TOCOPHERYL METHYLSILANOL, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL. MAY CONTAIN:IRON OXIDES (CI 77491), TITANIUM DIOXIDE (CI 77891), RED 30 LAKE (CI 73360), MICA (CI 77019), RED 27 LAKE (CI 45410), YELLOW 5 LAKE (CI 19140), RED 21 LAKE (CI 45380), RED 7 LAKE (CI 15850), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), TALC, BLUE 1 LAKE (CI 42090).

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VINO CAUTIVANTE - PURPLE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VINO CAUTIVANTE - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO GLAM - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO GLAM - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO PASIÓN - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO PASIÓN - RED

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

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA TENTACIÓN - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA TENTACIÓN - PINK

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

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA VIVA - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA VIVA - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAL ENSUEÑO - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAL ENSUEÑO - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN BAMBÚ - BROWN

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN BAMBÚ - BROWN

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

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATURAL DUNE - BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATURAL DUNE - BEIGE

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

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE CREAM - BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE CREAM - BEIGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE MOCCHA - BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE MOCCHA - BEIGE

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

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN HAVANA - BROWN

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN HAVANA - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN FANATIC - BROWN

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN FANATIC - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE ROSE- BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE ROSE- BEIGE

PRINCIPAL DISPLAY PANEL - Kit Carton

HD LONGWEAR
LONG-LASTING HIGH-DEFINITION
COLOR LIPSTICK SPF 20

ésika
PRO

Net Wt. 0.24 oz. e (7 g)

PRINCIPAL DISPLAY PANEL - Kit Carton
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  VINO CAUTIVANTE - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0023
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0023-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0023-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  PIMIENTA CALIENTE - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0024
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0024-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0024-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROJO GLAM - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0025
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
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0025-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0025-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROJO PASION - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0026
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0026-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0026-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  VINO DESEO - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0027
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0027-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0027-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  FUCSIA TENTACION - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0028
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0028-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0028-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  FUCSIA DELIRIO - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0029
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0029-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0029-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  FUCSIA VIBRANTE - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0030
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0030-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0030-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROSA VIVA - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0031
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0031-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0031-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  CORAL ENSUENO - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0032
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0032-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0032-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  MARRON BAMBU - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0033
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0033-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0033-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROSA FIORELLE - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0034
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0034-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0034-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  NATURAL DUNE - BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0035
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0035-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0035-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROJO FIESTA - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0036
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0036-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0036-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  NUDE CREAM - BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0037
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0037-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0037-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  NUDE MOCCHA - BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0048
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0048-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0048-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  FUCSIA SUBLIME - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0049
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0049-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0049-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  MARRON HAVANA - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0050
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0050-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0050-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  MARRON FANATIC - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0051
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0051-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0051-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  NUDE ROSE- BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0052
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0052-21 in 1 BOX01/27/201712/31/2021
1NDC:43596-0052-14 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 
octinoxate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0053
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0053-31 in 1 BOX01/27/201712/31/2021
1NDC:43596-0053-212 in 1 TRAY
1NDC:43596-0053-11 in 1 CONTAINER; Type 0: Not a Combination Product
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CONTAINER 0.5833 g
Part 21 CONTAINER 0.5833 g
Part 31 CONTAINER 0.5833 g
Part 41 CONTAINER 0.5833 g
Part 51 CONTAINER 0.5833 g
Part 61 CONTAINER 0.5833 g
Part 71 CONTAINER 0.5833 g
Part 81 CONTAINER 0.5833 g
Part 91 CONTAINER 0.5833 g
Part 101 CONTAINER 0.5833 g
Part 111 CONTAINER 0.5833 g
Part 121 CONTAINER 0.5833 g
Part 1 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  VINO CAUTIVANTE - PURPLE
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 2 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  VINO DESEO - PURPLE
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 3 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  MARRON BAMBU - BROWN
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 4 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  NUDE MOCCHA - BEIGE
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 5 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  PIMIENTA CALIENTE - RED
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 6 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROJO FIESTA - RED
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 7 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROJO PASION - RED
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 8 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  CORAL ENSUENO - RED
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 9 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  FUCSIA TENTACION - PINK
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 10 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  FUCSIA DELIRIO - PINK
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 11 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  NUDE ROSE- BEIGE
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Part 12 of 12
ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20  ROSA FIORELLE - PINK
octinoxate paste
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)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
MICA (UNII: V8A1AW0880)  
ISODODECANE (UNII: A8289P68Y2)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROMETHAMINE (UNII: 023C2WHX2V)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ACID RED 87 (UNII: TDQ283MPCW)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TALC (UNII: 7SEV7J4R1U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5833 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/27/201712/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(43596-0033, 43596-0023, 43596-0024, 43596-0025, 43596-0026, 43596-0027, 43596-0028, 43596-0029, 43596-0030, 43596-0031, 43596-0032, 43596-0034, 43596-0035, 43596-0036, 43596-0037, 43596-0048, 43596-0049, 43596-0050, 43596-0051, 43596-0052, 43596-0053)

Revised: 4/2025
Document Id: 321cbcf0-74ba-aac5-e063-6394a90aab0d
Set id: 1aa7f0a9-18c3-406d-a1b5-97d5d2160eeb
Version: 2
Effective Time: 20250406
 
Ventura Corporation LTD