ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA GALA MATE - PURPLE- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRAMBUESA GLAM MATE - RED- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA DESEO MATE - PINK- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA PINK MATE - PURPLE- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROJO PASION MATE - RED- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 PIMIENTA CALIENTE MATE - BROWN- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRESA PROFUNDO MATE - RED- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA VIBRANTE MATE - PURPLE- octinoxate lipstick 
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA VIVA MATE - PINK- octinoxate lipstick 
Ventura Corporation LTD

----------

Ésika PRO HD COLOR MATTE 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, DICAPRYLYL CARBONATE, POLYETHYLENE, OCTYLDODECANOL, SILICA, CAPRYLIC/CAPRIC TRIGLYCERIDE, ZEA MAYS (CORN) STARCH, NYLON-12, TRIDECYL TRIMELLITATE, CASTOR ISOSTEARATE BEESWAX SUCCINATE, POLYGLYCERYL-3 DIISOSTEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, ISOPROPYL LANOLATE, MICROCRYSTALLINE WAX, MICA, DIISOSTEARYL MALATE, C11-12 ISOPARAFFIN, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHENOXYETHANOL, BETA-SITOSTEROL, PHENYL TRIMETHICONE, FRAGRANCE, SILICA SILYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, OLEYL ALCOHOL, CHLORPHENESIN, CERAMIDE 3, DIMETHICONE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIOLEYL TOCOPHERYL METHYLSILANOL, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL. MAY CONTAIN:IRON OXIDES, TITANIUM DIOXIDE, RED 27 LAKE, RED 30 LAKE, YELLOW 5 LAKE, RED 7 LAKE, RED 21 LAKE, MICA, BLUE 1 LAKE, TALC.

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA GALA MATE - PURPLE

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA GALA MATE - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRAMBUESA GLAM MATE - RED

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRAMBUESA GLAM MATE - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA DESEO MATE - PINK

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA DESEO MATE - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA PINK MATE - PURPLE

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA PINK MATE - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO PASION MATE - RED

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO PASION MATE - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE MATE - BROWN

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE MATE - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRESA PROFUNDO MATE - RED

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRESA PROFUNDO MATE - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE MATE - PURPLE

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE MATE - PURPLE

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

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA VIVA MATE - PINK
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  FUCSIA GALA MATE - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-712
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-712-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-712-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  FRAMBUESA GLAM MATE - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-713
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-713-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-713-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  ROSA DESEO MATE - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-714
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-714-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-714-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  FUCSIA PINK MATE - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-715
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-715-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-715-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  ROJO PASION MATE - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-716
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-716-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-716-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  PIMIENTA CALIENTE MATE - BROWN
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-717
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-717-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-717-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  FRESA PROFUNDO MATE - RED
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-718
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-718-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-718-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  FUCSIA VIBRANTE MATE - PURPLE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-719
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-719-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-719-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20  ROSA VIVA MATE - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-720
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)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, CORN (UNII: O8232NY3SJ)  
NYLON-12 (UNII: 446U8J075B)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
MICA (UNII: V8A1AW0880)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
SHEA BUTTER (UNII: K49155WL9Y)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
CANDELILLA WAX (UNII: WL0328HX19)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
CERAMIDE NP (UNII: 4370DF050B)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
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. 27 (UNII: 2LRS185U6K)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
TALC (UNII: 7SEV7J4R1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-720-021 in 1 BOX12/14/201512/31/2021
1NDC:13537-720-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/14/201512/31/2021
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-712, 13537-713, 13537-714, 13537-715, 13537-716, 13537-717, 13537-718, 13537-719, 13537-720)

Revised: 3/2025
Document Id: 31188305-609c-bf7f-e063-6294a90ac7f4
Set id: 923a39ce-7793-4596-ad1a-52ffe9e396de
Version: 3
Effective Time: 20250324
 
Ventura Corporation LTD