Label: ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MARRON TOSCANA) - BROWN- octinoxate lipstick
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN- octinoxate lipstick
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - RED- octinoxate lipstick
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK ....... ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED (octinoxate) lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - RED (octinoxate) lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE (octinoxate) lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit [Ventura Corporation LTD]
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED- octinoxate lipstick
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - RED- octinoxate lipstick
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE- octinoxate lipstick
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit
-
Contains inactivated NDC Code(s)
NDC Code(s): 13537-001-01, 13537-001-02, 13537-002-03, 13537-002-04, view more13537-003-05, 13537-003-06, 13537-004-07, 13537-004-08, 13537-005-09, 13537-005-10, 13537-006-11, 13537-006-12, 13537-007-13, 13537-007-14, 13537-008-15, 13537-008-16, 13537-009-17, 13537-009-18, 13537-016-19, 13537-016-20, 13537-017-21, 13537-017-22, 13537-018-23, 13537-018-24, 13537-024-25, 13537-024-26, 13537-029-27, 13537-029-28, 13537-030-27, 13537-030-28, 13537-236-31, 13537-236-32 - 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 May 21, 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
-
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:
IRON OXIDES, MICA, TITANIUM DIOXIDE, YELLOW 5 LAKE, RED 30 LAKE, RED 7 LAKE, RED 27 LAKE, CALCIUM ALUMINUM BOROSILICATE, RED 6 LAKE, CARMINE, TIN OXIDE, TALC
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD MARRÓN TOSCANA) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD PIMIENTA CALIENTE) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD VINO CAUTIVANTE) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD ROSA VIVA) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD CORAL ENSUEÑO) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD ROJO GLAM) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD CAFÉ HABANO) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD FUCSIA VIBRANTE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD DURAZNO NUDE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD NARANJA PROVOCACIÓN) - ORANGE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD MELÓN 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) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD MAGENTA SWEET) - PURPLE
- PRINCIPAL DISPLAY PANEL - Kit Carton
-
INGREDIENTS AND APPEARANCE
ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 Â (HD MARRON TOSCANA) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-001 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-001-02 1 in 1 BOX 1 NDC:13537-001-01 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-002 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-002-04 1 in 1 BOX 1 NDC:13537-002-03 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD VINO CAUTIVANTE) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-003 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-003-06 1 in 1 BOX 1 NDC:13537-003-05 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSA VIVA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-004 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-004-08 1 in 1 BOX 1 NDC:13537-004-07 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CORAL ENSUENO) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-005 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-005-10 1 in 1 BOX 1 NDC:13537-005-09 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROJO GLAM) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-006 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-006-12 1 in 1 BOX 1 NDC:13537-006-11 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CAFE HABANO) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-007 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-007-14 1 in 1 BOX 1 NDC:13537-007-13 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-008 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-008-16 1 in 1 BOX 1 NDC:13537-008-15 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD DURAZNO NUDE) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-009 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-009-18 1 in 1 BOX 1 NDC:13537-009-17 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD NARANJA PROVOCACION) - ORANGE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-016 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-016-20 1 in 1 BOX 1 NDC:13537-016-19 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MELON INTENSE) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-017 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-017-22 1 in 1 BOX 1 NDC:13537-017-21 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD ROSADO CHIC) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-018 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-018-24 1 in 1 BOX 1 NDC:13537-018-23 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD CIRUELA GLAM) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-024 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-024-26 1 in 1 BOX 1 NDC:13537-024-25 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD FRAMBUESA ENCANTO) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-030 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-030-28 1 in 1 BOX 1 NDC:13537-030-27 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  (HD MAGENTA SWEET) - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-029 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  ALUMINUM OXIDE (UNII: LMI26O6933)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-029-28 1 in 1 BOX 1 NDC:13537-029-27 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 04/03/2014 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 Â
octinoxate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-236 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-236-32 2 in 1 CARTON 1 NDC:13537-236-31 1 in 1 TUBE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 7.8 g Part 2 1 TUBE 7.8 g Part 3 1 TUBE 7.8 g Part 4 1 TUBE 7.8 g Part 5 1 TUBE 7.8 g Part 6 1 TUBE 7.8 g Part 7 1 TUBE 7.8 g Part 8 1 TUBE 7.8 g Part 9 1 TUBE 7.8 g Part 10 1 TUBE 7.8 g Part 11 1 TUBE 7.8 g Part 12 1 TUBE 7.8 g Part 1 of 12 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  HD MARRON TOSCANA - 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 2 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 3 of 12 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  HD VINO CAUTIVANTE - 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 4 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 5 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 6 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 7 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 8 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 9 of 12 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  HD DURAZNO NUDE - 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 10 of 12 ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  HD NARANJA PROVOCACION - ORANGE
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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 11 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Part 12 of 12 ESIKA 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)  FERRIC OXIDE RED (UNII: 1K09F3G675)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  ALUMINUM OXIDE (UNII: LMI26O6933)  D&C RED NO. 30 (UNII: 2S42T2808B)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 27 (UNII: 2LRS185U6K)  CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)  D&C RED NO. 6 (UNII: 481744AI4O)  STANNIC OXIDE (UNII: KM7N50LOS6)  TALC (UNII: 7SEV7J4R1U)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.8 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 05/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/15/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-001, 13537-002, 13537-003, 13537-004, 13537-005, 13537-006, 13537-007, 13537-008, 13537-009, 13537-016, 13537-017, 13537-018, 13537-024, 13537-030, 13537-029, 13537-236)