Label: ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL ENSUENO) - RED- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO GLAM) - RED- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CAFE HABANO) - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FUCSIA VIBRANTE) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MELON INTENSE) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSADO CHIC) - PINK- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-577-01, 13537-577-02, 13537-578-03, 13537-578-04, view more13537-579-05, 13537-579-06, 13537-580-07, 13537-580-08, 13537-581-09, 13537-581-10, 13537-582-11, 13537-582-12, 13537-583-13, 13537-583-14, 13537-584-15, 13537-584-16, 13537-585-17, 13537-585-18, 13537-586-19, 13537-586-20, 13537-587-21, 13537-587-22, 13537-588-23, 13537-588-24, 13537-589-27, 13537-589-28 - Packager: Ventura Corporation LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 25, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
DIISOPROPYL DIMER DILINOLEATE, OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, TRIDECYL TRIMELLITATE, CASTOR ISOSTEARATE BEESWAX SUCCINATE, POLYGLYCERYL-3 DIISOSTEARATE, ISOPROPYL LANOLATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICA, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHENOXYETHANOL, BETA-SITOSTEROL, PHENYL TRIMETHICONE, SILICA, SILICA SILYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, FRAGRANCE, CAPRYLYL GLYCOL, DIMETHICONE, CHLORPHENESIN, CERAMIDE 3, TOCOPHERYL ACETATE, OLEYL ALCOHOL, TRIMETHYLSILOXYSILICATE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, DIOLEYL TOCOPHERYL METHYLSILANOL. May Contain: TITANIUM DIOXIDE, MICA, IRON OXIDES, RED 30 LAKE, RED 7 LAKE, YELLOW 5 LAKE, RED 27 LAKE, TALC, CALCIUM ALUMINUM BOROSILICATE, CARMINE, TIN OXIDE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD PIMIENTA CALIENTE) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD VINO CAUTIVANTE) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROSA VIVA) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CORAL ENSUENO) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROJO GLAM) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CAFE HABANO) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD FUCSIA VIBRANTE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD MELON INTENSE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD ROSADO CHIC) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD CIRUELA GLAM) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD FRAMBUESA ENCANTO) - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box (HD MAGENTA SWEET) - PURPLE
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 Â (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-577 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-577-02 1 in 1 BOX 1 NDC:13537-577-01 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD VINO CAUTIVANTE) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-578 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-578-04 1 in 1 BOX 1 NDC:13537-578-03 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSA VIVA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-579 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-579-06 1 in 1 BOX 1 NDC:13537-579-05 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CORAL ENSUENO) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-580 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-580-08 1 in 1 BOX 1 NDC:13537-580-07 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROJO GLAM) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-581 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-581-10 1 in 1 BOX 1 NDC:13537-581-09 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CAFE HABANO) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-582 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-582-12 1 in 1 BOX 1 NDC:13537-582-11 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-583 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-583-14 1 in 1 BOX 1 NDC:13537-583-13 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MELON INTENSE) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-584 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-584-16 1 in 1 BOX 1 NDC:13537-584-15 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSADO CHIC) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-585 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-585-18 1 in 1 BOX 1 NDC:13537-585-17 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CIRUELA GLAM) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-586 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-586-20 1 in 1 BOX 1 NDC:13537-586-19 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FRAMBUESA ENCANTO) - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-587 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-587-22 1 in 1 BOX 1 NDC:13537-587-21 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MAGENTA SWEET) - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-588 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-588-24 1 in 1 BOX 1 NDC:13537-588-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 Â
octinoxate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-589 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-589-28 2 in 1 BOX 1 NDC:13537-589-27 1 in 1 TUBE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 4 g Part 2 1 TUBE 4 g Part 3 1 TUBE 4 g Part 4 1 TUBE 4 g Part 5 1 TUBE 4 g Part 6 1 TUBE 4 g Part 7 1 TUBE 4 g Part 8 1 TUBE 4 g Part 9 1 TUBE 4 g Part 10 1 TUBE 4 g Part 11 1 TUBE 4 g Part 12 1 TUBE 4 g Part 1 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 2 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD VINO CAUTIVANTE) - BROWN
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 3 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSA VIVA) - PINK
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 4 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CORAL ENSUENO) - RED
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 5 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROJO GLAM) - RED
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 6 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CAFE HABANO) - BROWN
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 7 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 8 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MELON INTENSE) - PINK
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 9 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSADO CHIC) - PINK
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 10 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CIRUELA GLAM) - RED
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 11 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FRAMBUESA ENCANTO) - PURPLE
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Part 12 of 12 ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MAGENTA SWEET) - PURPLE
octinoxate lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.068 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  CARNAUBA WAX (UNII: R12CBM0EIZ)  MICA (UNII: V8A1AW0880)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  SHEA BUTTER (UNII: K49155WL9Y)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  CANDELILLA WAX (UNII: WL0328HX19)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  DIMETHICONE (UNII: 92RU3N3Y1O)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE 3 (UNII: 4370DF050B)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  OLEYL ALCOHOL (UNII: 172F2WN8DV)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  FD&C YELLOW No. 5 (UNII: I753WB2F1M)  D&C RED No. 27 (UNII: 2LRS185U6K)  TALC (UNII: 7SEV7J4R1U)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  STANNIC OXIDE (UNII: KM7N50LOS6)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/17/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-577, 13537-578, 13537-579, 13537-580, 13537-581, 13537-582, 13537-583, 13537-584, 13537-585, 13537-586, 13537-587, 13537-588, 13537-589)