Label: ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOUR) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO LUJURIA) - RED (octinoxate and oxybenzon ....... HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA EXOTIC) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY EXOTIC) - PURPLE- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOR EXOTIC) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 SPF 25- octinoxate and oxybenzone kit
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-590-01, 13537-590-02, 13537-591-03, 13537-591-04, view more13537-592-05, 13537-592-06, 13537-593-07, 13537-593-08, 13537-594-09, 13537-594-10, 13537-595-11, 13537-595-12, 13537-596-13, 13537-596-14, 13537-597-15, 13537-597-16, 13537-598-17, 13537-598-18, 13537-599-19, 13537-599-20, 13537-609-21, 13537-609-22, 13537-610-23, 13537-610-24, 13537-611-23, 13537-611-24, 13537-612-23, 13537-612-24, 13537-613-23, 13537-613-24, 13537-614-23, 13537-614-24, 13537-615-23, 13537-615-24, 13537-616-23, 13537-616-24, 13537-617-23, 13537-617-24, 13537-618-23, 13537-618-24, 13537-619-23, 13537-619-24, 13537-620-23, 13537-620-24, 13537-621-23, 13537-621-24, 13537-622-23, 13537-622-24, 13537-623-23, 13537-623-24, 13537-624-23, 13537-624-24, 13537-664-23, 13537-664-24, 13537-665-23, 13537-665-24, 13537-666-23, 13537-666-24, 13537-667-23, 13537-667-24, 13537-668-23, 13537-668-24, 13537-669-27, 13537-669-28, 13537-691-23, 13537-691-24, 13537-692-23, 13537-692-24, 13537-693-23, 13537-693-24, 13537-694-23, 13537-694-24, 13537-695-23, 13537-695-24, 13537-696-23, 13537-696-24, 13537-697-23, 13537-697-24, 13537-698-23, 13537-698-24, 13537-699-23, 13537-699-24, 13537-700-23, 13537-700-24, 13537-701-23, 13537-701-24 - 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 December 7, 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 INGREDIENT
- Uses
- Warnings
- Directions
- Other information
-
Inactive ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, OZOKERITE, WATER, POLYETHYLENE, TRIDECYL STEARATE, POLYGLYCERYL-3 DIISOSTEARATE, POLYMETHYL METHACRYLATE, COPERNICIA CERIFERA (CARNAUBA) WAX, GLYCERIN, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, FRAGRANCE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM STARCH OCTENYLSUCCINATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, PROPYLENE GLYCOL, LIMONIUM GERBERI EXTRACT, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCINE SOJA (SOYBEAN) OIL, TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE, VITIS VINIFERA (GRAPE) FRUIT EXTRACT. MAY CONTAIN : MICA, TITANIUM DIOXIDE, RED 30 LAKE, IRON OXIDES, YELLOW 5 LAKE, RED 21 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, CARMINE.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box – All Shades
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-590 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-590-02 1 in 1 BOX 1 NDC:13537-590-01 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 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-591 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-591-04 1 in 1 BOX 1 NDC:13537-591-03 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-592 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-592-06 1 in 1 BOX 1 NDC:13537-592-05 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-593 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-593-08 1 in 1 BOX 1 NDC:13537-593-07 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-594 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-594-10 1 in 1 BOX 1 NDC:13537-594-09 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-595 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-595-12 1 in 1 BOX 1 NDC:13537-595-11 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-596 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-596-14 1 in 1 BOX 1 NDC:13537-596-13 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-597 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-597-16 1 in 1 BOX 1 NDC:13537-597-15 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-598 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-598-18 1 in 1 BOX 1 NDC:13537-598-17 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-599 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-599-20 1 in 1 BOX 1 NDC:13537-599-19 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NARANJA PRIMAVERA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-609 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-609-22 1 in 1 BOX 1 NDC:13537-609-21 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-610-24 1 in 1 BOX 1 NDC:13537-610-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-611 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-611-24 1 in 1 BOX 1 NDC:13537-611-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-612 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-612-24 1 in 1 BOX 1 NDC:13537-612-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CANELA NUDE) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-613 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-613-24 1 in 1 BOX 1 NDC:13537-613-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MORA GLAM) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-614 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-614-24 1 in 1 BOX 1 NDC:13537-614-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL INTENSE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-615 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-615-24 1 in 1 BOX 1 NDC:13537-615-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRESA COQUETA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-616 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-616-24 1 in 1 BOX 1 NDC:13537-616-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE FEMME) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-617 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-617-24 1 in 1 BOX 1 NDC:13537-617-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-618 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-618-24 1 in 1 BOX 1 NDC:13537-618-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-619 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-619-24 1 in 1 BOX 1 NDC:13537-619-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ROMANTICA FEMME) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-620 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-620-24 1 in 1 BOX 1 NDC:13537-620-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE FEMME) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-621-24 1 in 1 BOX 1 NDC:13537-621-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO FEMME) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-622-24 1 in 1 BOX 1 NDC:13537-622-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA GEOMETRIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-623 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-623-24 1 in 1 BOX 1 NDC:13537-623-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA PRISMA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-624 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-624-24 1 in 1 BOX 1 NDC:13537-624-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NARANJA ESFERA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-664 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-664-24 1 in 1 BOX 1 NDC:13537-664-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NUDE INFINITO) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-665 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-665-24 1 in 1 BOX 1 NDC:13537-665-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO ESIKA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-666 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-666-24 1 in 1 BOX 1 NDC:13537-666-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON TOPACIO) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-667 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-667-24 1 in 1 BOX 1 NDC:13537-667-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA AMATISTA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-668 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-668-24 1 in 1 BOX 1 NDC:13537-668-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 11/23/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL QUARZO) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-691 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-691-24 1 in 1 BOX 1 NDC:13537-691-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NUDE PRISMA) - BEIGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-692 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-692-24 1 in 1 BOX 1 NDC:13537-692-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (DORADO ESENCIAL) - YELLOW
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-693 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-693-24 1 in 1 BOX 1 NDC:13537-693-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE EXOTIC) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-694 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-694-24 1 in 1 BOX 1 NDC:13537-694-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO EXOTIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-695 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-695-24 1 in 1 BOX 1 NDC:13537-695-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL CHIC EXOTIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-696 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-696-24 1 in 1 BOX 1 NDC:13537-696-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-697 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-697-24 1 in 1 BOX 1 NDC:13537-697-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO EXOTIC) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-698 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-698-24 1 in 1 BOX 1 NDC:13537-698-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA EXOTIC) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-699 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-699-24 1 in 1 BOX 1 NDC:13537-699-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY EXOTIC) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-700-24 1 in 1 BOX 1 NDC:13537-700-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOR EXOTIC) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-701-24 1 in 1 BOX 1 NDC:13537-701-23 4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/18/2015 ESIKA HYDRACOLOR 2 IN 1 SPF 25
octinoxate and oxybenzone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-669 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-669-28 2 in 1 BOX 1 NDC:13537-669-27 1 in 1 TUBE Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 8 g Part 2 1 TUBE 8 g Part 3 1 TUBE 8 g Part 4 1 TUBE 8 g Part 5 1 TUBE 8 g Part 6 1 TUBE 8 g Part 7 1 TUBE 8 g Part 8 1 TUBE 8 g Part 9 1 TUBE 8 g Part 10 1 TUBE 8 g Part 11 1 TUBE 8 g Part 12 1 TUBE 8 g Part 13 1 TUBE 8 g Part 14 1 TUBE 8 g Part 15 1 TUBE 8 g Part 16 1 TUBE 8 g Part 17 1 TUBE 8 g Part 18 1 TUBE 8 g Part 19 1 TUBE 8 g Part 20 1 TUBE 8 g Part 21 1 TUBE 8 g Part 22 1 TUBE 8 g Part 23 1 TUBE 8 g Part 24 1 TUBE 8 g Part 25 1 TUBE 8 g Part 26 1 TUBE 8 g Part 27 1 TUBE 8 g Part 28 1 TUBE 8 g Part 29 1 TUBE 8 g Part 30 1 TUBE 8 g Part 31 1 TUBE 8 g Part 32 1 TUBE 8 g Part 33 1 TUBE 8 g Part 34 1 TUBE 8 g Part 35 1 TUBE 8 g Part 36 1 TUBE 8 g Part 37 1 TUBE 8 g Part 38 1 TUBE 8 g Part 39 1 TUBE 8 g Part 40 1 TUBE 8 g Part 41 1 TUBE 8 g Part 42 1 TUBE 8 g Part 1 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 2 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 3 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 4 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 5 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 6 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 7 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 8 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 9 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 10 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 11 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NARANJA PRIMAVERA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 12 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 13 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 14 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 15 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CANELA NUDE) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 16 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MORA GLAM) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 17 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL INTENSE) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 18 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRESA COQUETA) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 19 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE FEMME) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 20 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (GRANATE SEDUCTOR FEMME) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 21 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE FEMME) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 22 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ROMANTICA FEMME) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 23 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE FEMME) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 24 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO FEMME) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 25 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA GEOMETRIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 26 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA PRISMA) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 27 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NARANJA ESFERA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 28 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NUDE INFINITO) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 29 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO ESIKA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 30 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON TOPACIO) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 31 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA AMATISTA) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 11/23/2015 Part 32 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL QUARZO) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 33 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (NUDE PRISMA) - BEIGE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 34 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (DORADO ESENCIAL) - YELLOW
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 35 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (PIMIENTA CALIENTE EXOTIC) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 36 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROSA ENCANTO EXOTIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 37 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (CORAL CHIC EXOTIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 38 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 39 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO EXOTIC) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 40 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA EXOTIC) - RED
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 41 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY EXOTIC) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Part 42 of 42 ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOR EXOTIC) - BROWN
octinoxate and oxybenzone lipstickProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.0664 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.0151 g in 1 g Inactive Ingredients Ingredient Name Strength DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW) TRIDECYL TRIMELLITATE (UNII: FY36J270ES) ETHYLHEXYL PALMITATE (UNII: 2865993309) WATER (UNII: 059QF0KO0R) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TRIDECYL STEARATE (UNII: A8OE252M6L) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CARNAUBA WAX (UNII: R12CBM0EIZ) GLYCERIN (UNII: PDC6A3C0OX) NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PHENOXYETHANOL (UNII: HIE492ZZ3T) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CERAMIDE 3 (UNII: 4370DF050B) CHLORPHENESIN (UNII: I670DAL4SZ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHEA BUTTER (UNII: K49155WL9Y) SOYBEAN OIL (UNII: 241ATL177A) TOCOPHEROL (UNII: R0ZB2556P8) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) WINE GRAPE (UNII: 3GOV20705G) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 30 (UNII: 2S42T2808B) ALUMINUM OXIDE (UNII: LMI26O6933) FERRIC OXIDE RED (UNII: 1K09F3G675) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 21 (UNII: 08744Z6JNY) D&C RED NO. 27 (UNII: 2LRS185U6K) D&C RED NO. 7 (UNII: ECW0LZ41X8) TALC (UNII: 7SEV7J4R1U) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 12/18/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/25/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-590, 13537-591, 13537-592, 13537-593, 13537-594, 13537-595, 13537-596, 13537-597, 13537-598, 13537-599, 13537-609, 13537-610, 13537-611, 13537-612, 13537-613, 13537-614, 13537-615, 13537-616, 13537-617, 13537-618, 13537-619, 13537-620, 13537-621, 13537-622, 13537-623, 13537-624, 13537-664, 13537-665, 13537-666, 13537-667, 13537-668, 13537-669, 13537-691, 13537-692, 13537-693, 13537-694, 13537-695, 13537-696, 13537-697, 13537-698, 13537-699, 13537-700, 13537-701)