Label: ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FUCSIA) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CEREZA) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (ROSA) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (RUBI) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (AMBAR) - YELLOW- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FRESA) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CHAMPAGNE) - BEIGE- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (COBRE) - ORANGE- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (PIMIENTA CALIENTE) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (DIAMANTE ROSA) - PINK- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (MELON) - ORANGE- octinoxate lipstick
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (VINO) - BEIGE- octinoxate lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-833-01, 14783-833-02, 14783-834-01, 14783-834-02, view more14783-835-01, 14783-835-02, 14783-836-01, 14783-836-02, 14783-837-01, 14783-837-02, 14783-838-01, 14783-838-02, 14783-839-01, 14783-839-02, 14783-840-01, 14783-840-02, 14783-841-01, 14783-841-02, 14783-842-01, 14783-842-02, 14783-843-01, 14783-843-02, 14783-844-01, 14783-844-02 - Packager: Ventura International LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 31, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive Ingredients
LIPSTICK
DIISOPROPYL DIMER DILINOLEATE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYL PALMITATE, TRIDECYL TRIMELLITATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, SYNTHETIC BEESWAX, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, SILICA SILYLATE, PHENOXYETHANOL, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BETA-SITOSTEROL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, DIMETHICONE, FRAGRANCE, CERAMIDE 3, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TRIMETHYLSILOXYSILICATE.
GLOSS
OCTYLDODECANOL, TRIDECYL TRIMELLITATE, POLYETHYLENE, OZOKERITE, PARAFFIN, COPERNICIA CERIFERA (CARNAUBA) WAX, PHENOXYETHANOL, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TOCOPHERYL ACETATE, DIMETHICONE, FRAGRANCE, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE.
MAY CONTAIN:
SYNTHETIC FLUORPHLOGOPITE, RED 21 LAKE, MICA, IRON OXIDES, CALCIUM SODIUM BOROSILICATE, YELLOW 5 LAKE, TITANIUM DIOXIDE, RED 27 LAKE, RED 7 LAKE, TALC, SILICA, RED 30 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, TIN OXIDE, BLUE 1 LAKE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (FUCSIA) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (CEREZA) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (ROSA) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (RUBI) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (AMBAR) - YELLOW
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (FRESA) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (CHAMPAGNE) - BEIGE
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (COBRE) - ORANGE
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (PIMIENTA CALIENTE) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (DIAMANTE ROSA) - PINK
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (MELON) - ORANGE
- PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (VINO) - BEIGE
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INGREDIENTS AND APPEARANCE
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 Â (FUCSIA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-833 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-833-02 1 in 1 BOX 1 NDC:14783-833-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (CEREZA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-834 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-834-02 1 in 1 BOX 1 NDC:14783-834-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (ROSA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-835 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-835-02 1 in 1 BOX 1 NDC:14783-835-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (RUBI) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-836 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-836-02 1 in 1 BOX 1 NDC:14783-836-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (AMBAR) - YELLOW
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-837 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-837-02 1 in 1 BOX 1 NDC:14783-837-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (FRESA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-838 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-838-02 1 in 1 BOX 1 NDC:14783-838-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (CHAMPAGNE) - BEIGE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-839 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-839-02 1 in 1 BOX 1 NDC:14783-839-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (COBRE) - ORANGE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-840 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-840-02 1 in 1 BOX 1 NDC:14783-840-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (PIMIENTA CALIENTE) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-841 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-841-02 1 in 1 BOX 1 NDC:14783-841-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (DIAMANTE ROSA) - PINK
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-842 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-842-02 1 in 1 BOX 1 NDC:14783-842-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (MELON) - ORANGE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-843 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-843-02 1 in 1 BOX 1 NDC:14783-843-01 3.8 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 08/31/2015 ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (VINO) - BEIGE
octinoxate lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-844 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g  in 1 g Inactive Ingredients Ingredient Name Strength DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  OCTYLDODECANOL (UNII: 461N1O614Y)  MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  ETHYLHEXYL PALMITATE (UNII: 2865993309)  TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  CANDELILLA WAX (UNII: WL0328HX19)  HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  CARNAUBA WAX (UNII: R12CBM0EIZ)  SHEA BUTTER (UNII: K49155WL9Y)  TRIDECYL STEARATE (UNII: A8OE252M6L)  NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  .BETA.-SITOSTEROL (UNII: S347WMO6M4)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  DIMETHICONE (UNII: 92RU3N3Y1O)  CERAMIDE 3 (UNII: 4370DF050B)  PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  PARAFFIN (UNII: I9O0E3H2ZE)  D&C RED NO. 21 (UNII: 08744Z6JNY)  ALUMINUM OXIDE (UNII: LMI26O6933)  MICA (UNII: V8A1AW0880)  FERRIC OXIDE RED (UNII: 1K09F3G675)  FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  D&C RED NO. 27 (UNII: 2LRS185U6K)  D&C RED NO. 7 (UNII: ECW0LZ41X8)  TALC (UNII: 7SEV7J4R1U)  SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  D&C RED NO. 30 (UNII: 2S42T2808B)  STANNIC OXIDE (UNII: KM7N50LOS6)  FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-844-02 1 in 1 BOX 1 NDC:14783-844-01 3.8 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 08/31/2015 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-833, 14783-834, 14783-835, 14783-836, 14783-837, 14783-838, 14783-839, 14783-840, 14783-841, 14783-842, 14783-843, 14783-844)