Label: ESIKA PRO PERFECT MATCH VOLUMEN (FRESA TENTACION) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (CAFE MISTERIO) - BROWN- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (ROSA DESEO) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (DURAZNO AMOR) - ORANGE- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (ROSA GOLOSA) - PINK- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (CORAL SEDUCTOR) - PINK- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (CEREZA SEXY) - PINK- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (FUCSIA SENSUAL) - PINK- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (ROJO PASION) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (VINO CALIENTE) - PURPLE- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (PIMIENTA CALIENTE) - BROWN- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (CAFE PARISO) - BROWN- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (ROSE BLOOM) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (FRESA ENERGY) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (BURGUNDY VITAL) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (VINO SUBLIME) - RED- octinoxate lipstick
ESIKA PRO PERFECT MATCH VOLUMEN (ROJO RADIANT) - RED- octinoxate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-180-01, 13537-180-02, 13537-181-03, 13537-181-04, view more13537-182-05, 13537-182-06, 13537-183-07, 13537-183-08, 13537-184-09, 13537-184-10, 13537-185-11, 13537-185-12, 13537-186-13, 13537-186-14, 13537-302-15, 13537-302-16, 13537-304-17, 13537-304-18, 13537-480-19, 13537-480-20, 13537-481-21, 13537-481-22, 13537-761-01, 13537-761-02, 13537-762-01, 13537-762-02, 13537-763-01, 13537-763-02, 13537-764-01, 13537-764-02, 13537-765-01, 13537-765-02, 13537-766-01, 13537-766-02 - 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 October 4, 2017
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
LIPSTICK
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SYNTHETIC BEESWAX, POLYETHYLENE, TRIDECYL STEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, POLYGLYCERYL-3 DIISOSTEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, HYDROGENATED VEGETABLE OIL, SILICA DIMETHYL SILYLATE, PHENOXYETHANOL, CETEARYL ETHYLHEXANOATE, GLYCERIN, FRAGRANCE, CAPRYLYL GLYCOL, CHLORPHENESIN, CERAMIDE 3, SODIUM SACCHARIN, SORBITAN ISOSTEARATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PORTULACA PILOSA EXTRACT, SUCROSE COCOATE, PALMITOYL TRIPEPTIDE-38, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.
MAY CONTAIN :
IRON OXIDES, MANGANESE VIOLET, MICA, RED 30 LAKE, TITANIUM DIOXIDE, RED 21 LAKE, YELLOW 5 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE.
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INGREDIENTS
LIP LINER
ISODODECANE, DIMETHICONE, TRIMETHYLSILOXYSILICATE, CYCLOPENTASILOXANE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, PHENOXYETHANOL, FRAGRANCE, CAPRYLYL GLYCOL, CHLORPHENESIN, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.
MAY CONTAIN :
IRON OXIDES, MANGANESE VIOLET, TITANIUM DIOXIDE, RED 7 LAKE, RED 40 LAKE, MICA, RED 27 LAKE, YELLOW 5 LAKE, RED 21 LAKE, BLUE 1 LAKE, TALC.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FRESA TENTACION) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CAFE MISTERIO) - BROWN
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROSA DESEO) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (DURAZNO AMOR) - ORANGE
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROSA GOLOSA) - PINK
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CORAL SEDUCTOR) - PINK
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CEREZA SEXY) - PINK
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FUCSIA SENSUAL) - PINK
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROJO PASION) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (VINO CALIENTE) - PURPLE
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (PIMIENTA CALIENTE) - BROWN
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CAFÉ PARISO) - BROWN
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROSE BLOOM) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FRESA ENERGY) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (BURGUNDY VITAL) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (VINO SUBLIME) - RED
- PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROJO RADIANT) - RED
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INGREDIENTS AND APPEARANCE
ESIKA PRO PERFECT MATCH VOLUMEN Â (FRESA TENTACION) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-180 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-180-02 1 in 1 BOX 07/10/2015 1 NDC:13537-180-01 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (CAFE MISTERIO) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-181 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-181-04 1 in 1 BOX 07/10/2015 1 NDC:13537-181-03 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (ROSA DESEO) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-182 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-182-06 1 in 1 BOX 07/10/2015 1 NDC:13537-182-05 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (DURAZNO AMOR) - ORANGE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-183 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-183-08 1 in 1 BOX 07/10/2015 1 NDC:13537-183-07 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (ROSA GOLOSA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-184 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-184-10 1 in 1 BOX 07/10/2015 1 NDC:13537-184-09 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (CORAL SEDUCTOR) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-185 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-185-12 1 in 1 BOX 07/10/2015 1 NDC:13537-185-11 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (CEREZA SEXY) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-186 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-186-14 1 in 1 BOX 07/10/2015 1 NDC:13537-186-13 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (FUCSIA SENSUAL) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-302 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-302-16 1 in 1 BOX 07/10/2015 1 NDC:13537-302-15 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (ROJO PASION) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-304 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-304-18 1 in 1 BOX 07/10/2015 1 NDC:13537-304-17 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (VINO CALIENTE) - PURPLE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-480 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-480-20 1 in 1 BOX 07/10/2015 1 NDC:13537-480-19 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (PIMIENTA CALIENTE) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-481 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-481-22 1 in 1 BOX 07/10/2015 1 NDC:13537-481-21 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (CAFE PARISO) - BROWN
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-761 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-761-02 1 in 1 BOX 07/10/2015 1 NDC:13537-761-01 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (ROSE BLOOM) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-762 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-762-02 1 in 1 BOX 07/10/2015 1 NDC:13537-762-01 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (FRESA ENERGY) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-763 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-763-02 1 in 1 BOX 07/10/2015 1 NDC:13537-763-01 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (BURGUNDY VITAL) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-764 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-764-02 1 in 1 BOX 07/10/2015 1 NDC:13537-764-01 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (VINO SUBLIME) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-765 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-765-02 1 in 1 BOX 07/10/2015 1 NDC:13537-765-01 2.2 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 07/10/2015 ESIKA PRO PERFECT MATCH VOLUMEN  (ROJO RADIANT) - RED
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-766 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 g  in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  TRIDECYL STEARATE (UNII: A8OE252M6L)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  SHEA BUTTER (UNII: K49155WL9Y)  SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  GLYCERIN (UNII: PDC6A3C0OX)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  CHLORPHENESIN (UNII: I670DAL4SZ)  CERAMIDE NP (UNII: 4370DF050B)  SACCHARIN SODIUM (UNII: SB8ZUX40TY)  SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  SUCROSE COCOATE (UNII: 3H18P0UK73)  PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  FERRIC OXIDE RED (UNII: 1K09F3G675)  MANGANESE VIOLET (UNII: 72M48QQV8Q)  MICA (UNII: V8A1AW0880)  D&C RED NO. 30 (UNII: 2S42T2808B)  ALUMINUM OXIDE (UNII: LMI26O6933)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  D&C RED NO. 21 (UNII: 08744Z6JNY)  TALC (UNII: 7SEV7J4R1U)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  LIMONENE, (+)- (UNII: GFD7C86Q1W)  LINALOOL, (+/-)- (UNII: D81QY6I88E)  .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-766-02 1 in 1 BOX 07/10/2015 1 NDC:13537-766-01 2.2 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 07/10/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-180, 13537-181, 13537-182, 13537-183, 13537-184, 13537-185, 13537-186, 13537-302, 13537-304, 13537-480, 13537-481, 13537-761, 13537-762, 13537-763, 13537-764, 13537-765, 13537-766)