Label: ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA GALA MATE - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRAMBUESA GLAM MATE - RED- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA DESEO MATE - PINK- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA PINK MATE - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROJO PASION MATE - RED- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 PIMIENTA CALIENTE MATE - BROWN- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRESA PROFUNDO MATE - RED- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA VIBRANTE MATE - PURPLE- octinoxate lipstick
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA VIVA MATE - PINK- octinoxate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-712-01, 13537-712-02, 13537-713-01, 13537-713-02, view more13537-714-01, 13537-714-02, 13537-715-01, 13537-715-02, 13537-716-01, 13537-716-02, 13537-717-01, 13537-717-02, 13537-718-01, 13537-718-02, 13537-719-01, 13537-719-02, 13537-720-01, 13537-720-02 - Packager: Ventura Corporation LTD
- Category: HUMAN OTC DRUG LABEL
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 April 21, 2016
If you are a healthcare professional or from the pharmaceutical industry 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, DICAPRYLYL CARBONATE, POLYETHYLENE, OCTYLDODECANOL, SILICA, CAPRYLIC/CAPRIC TRIGLYCERIDE, ZEA MAYS (CORN) STARCH, NYLON-12, TRIDECYL TRIMELLITATE, CASTOR ISOSTEARATE BEESWAX SUCCINATE, POLYGLYCERYL-3 DIISOSTEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, ISOPROPYL LANOLATE, MICROCRYSTALLINE WAX, MICA, DIISOSTEARYL MALATE, C11-12 ISOPARAFFIN, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHENOXYETHANOL, BETA-SITOSTEROL, PHENYL TRIMETHICONE, FRAGRANCE, SILICA SILYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, OLEYL ALCOHOL, CHLORPHENESIN, CERAMIDE 3, DIMETHICONE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIOLEYL TOCOPHERYL METHYLSILANOL, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE, RED 27 LAKE, RED 30 LAKE, YELLOW 5 LAKE, RED 7 LAKE, RED 21 LAKE, MICA, BLUE 1 LAKE, TALC.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA GALA MATE - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRAMBUESA GLAM MATE - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA DESEO MATE - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA PINK MATE - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO PASION MATE - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE MATE - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRESA PROFUNDO MATE - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE MATE - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA VIVA MATE - PINK
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INGREDIENTS AND APPEARANCE
ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA GALA MATE - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-712 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-712-02 1 in 1 BOX 12/14/2015 1 NDC:13537-712-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRAMBUESA GLAM MATE - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-713 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-713-02 1 in 1 BOX 12/14/2015 1 NDC:13537-713-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA DESEO MATE - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-714 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-714-02 1 in 1 BOX 12/14/2015 1 NDC:13537-714-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA PINK MATE - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-715 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-715-02 1 in 1 BOX 12/14/2015 1 NDC:13537-715-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROJO PASION MATE - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-716 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-716-02 1 in 1 BOX 12/14/2015 1 NDC:13537-716-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 PIMIENTA CALIENTE MATE - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-717 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-717-02 1 in 1 BOX 12/14/2015 1 NDC:13537-717-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRESA PROFUNDO MATE - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-718 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-718-02 1 in 1 BOX 12/14/2015 1 NDC:13537-718-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA VIBRANTE MATE - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-719 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-719-02 1 in 1 BOX 12/14/2015 1 NDC:13537-719-01 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 12/14/2015 ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA VIVA MATE - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-720 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) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OCTYLDODECANOL (UNII: 461N1O614Y) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) STARCH, CORN (UNII: O8232NY3SJ) NYLON-12 (UNII: 446U8J075B) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) MICA (UNII: V8A1AW0880) DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ) C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SHEA BUTTER (UNII: K49155WL9Y) PHENOXYETHANOL (UNII: HIE492ZZ3T) .BETA.-SITOSTEROL (UNII: S347WMO6M4) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CANDELILLA WAX (UNII: WL0328HX19) CAPRYLYL GLYCOL (UNII: 00YIU5438U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) OLEYL ALCOHOL (UNII: 172F2WN8DV) CHLORPHENESIN (UNII: I670DAL4SZ) CERAMIDE NP (UNII: 4370DF050B) DIMETHICONE (UNII: 92RU3N3Y1O) ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 27 (UNII: 2LRS185U6K) ALUMINUM OXIDE (UNII: LMI26O6933) D&C RED NO. 30 (UNII: 2S42T2808B) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 21 (UNII: 08744Z6JNY) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-720-02 1 in 1 BOX 12/14/2015 1 NDC:13537-720-01 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 12/14/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-712, 13537-713, 13537-714, 13537-715, 13537-716, 13537-717, 13537-718, 13537-719, 13537-720)