Label: ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED- octinoxate and oxybenzone lipstick
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED- octinoxate and oxybenzone lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-061-01, 13537-061-02, 13537-064-03, 13537-064-04, view more13537-065-05, 13537-065-06, 13537-066-07, 13537-066-08, 13537-067-09, 13537-067-10, 13537-068-11, 13537-068-12, 13537-069-13, 13537-069-14, 13537-070-15, 13537-070-16, 13537-071-17, 13537-071-18, 13537-072-19, 13537-072-20, 13537-073-21, 13537-073-22, 13537-074-23, 13537-074-24, 13537-075-25, 13537-075-26, 13537-076-27, 13537-076-28, 13537-077-29, 13537-077-30 - 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 April 15, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
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Warnings
Skin Cancer / Skin Aging Alert
- Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Rinse with water to remove. If swallowed, get medical help or contact a Poison Control Center right away.
- For external use only.
- Directions
- Other information
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Inactive ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, OZOKERITE, AQUA (WATER), POLYETHYLENE, POLYGLYCERYL-3 DIISOSTEARATE, POLYMETHYL METHACRYLATE, TRIDECYL STEARATE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), GLYCERIN, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM STARCH OCTENYLSUCCINATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, COCOS NUCIFERA OIL (COCOS NUCIFERA (COCONUT) OIL), ALOE BARBADENSIS LEAF EXTRACT, PARFUM (FRAGRANCE), CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, PROPYLENE GLYCOL, LIMONIUM GERBERI EXTRACT, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), GLYCINE SOJA OIL (GLYCINE SOJA (SOYBEAN) OIL ), TOCOPHEROL, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SILICA, SODIUM CHLORIDE, VITIS VINIFERA FRUIT EXTRACT (VITIS VINIFERA (GRAPE) FRUIT EXTRACT), alpha-ISOMETHYL IONONE, D-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.
May contain:
CI 77019 (MICA), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 45380 (RED 21 LAKE), CI 19140 (YELLOW 5 LAKE), CI 15850 (RED 7 LAKE), CI 45410 (RED 27 LAKE), CI 77499 (IRON OXIDES), CI 77492 (IRON OXIDES), TALC, PEG-8 METHYL ETHER TRIETHOXYSILANE, CI 75470 (CARMINE). - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR) - BROWN
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO LUJURIA) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGOÑA SEXY) - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMÁNTICA) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANÍA) - RED
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA DULZURA) - PINK
- PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN
- PRINCIPAL DISPLAY PANEL - 14 Tube Kit
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INGREDIENTS AND APPEARANCE
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-061 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-061-02 1 in 1 BOX 1 NDC:13537-061-01 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-064 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-064-04 1 in 1 BOX 1 NDC:13537-064-03 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-065 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-065-06 1 in 1 BOX 1 NDC:13537-065-05 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-066 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-066-08 1 in 1 BOX 1 NDC:13537-066-07 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-067 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-067-10 1 in 1 BOX 1 NDC:13537-067-09 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-068 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-068-12 1 in 1 BOX 1 NDC:13537-068-11 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (BORGONA SEXY) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-069 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-069-14 1 in 1 BOX 1 NDC:13537-069-13 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FUCSIA CAUTIVANTE) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-070 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-070-16 1 in 1 BOX 1 NDC:13537-070-15 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-071 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-071-18 1 in 1 BOX 1 NDC:13537-071-17 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-072 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-072-20 1 in 1 BOX 1 NDC:13537-072-19 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (NARANJA PRIMAVERA) - ORANGE
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-073 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-073-22 1 in 1 BOX 1 NDC:13537-073-21 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-074 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-074-24 1 in 1 BOX 1 NDC:13537-074-23 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-075 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-075-26 1 in 1 BOX 1 NDC:13537-075-25 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-076 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-076-28 1 in 1 BOX 1 NDC:13537-076-27 4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25
octinoxate and oxybenzone kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-077 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-077-29 1 in 1 CASE 2 NDC:13537-077-30 1 in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CASE 0.57 g Part 2 1 CASE 0.57 g Part 3 1 CASE 0.57 g Part 4 1 CASE 0.57 g Part 5 1 CASE 0.57 g Part 6 1 CASE 0.57 g Part 7 1 CASE 0.57 g Part 8 1 CASE 0.57 g Part 9 1 CASE 0.57 g Part 10 1 CASE 0.57 g Part 11 1 CASE 0.57 g Part 12 1 CASE 0.57 g Part 13 1 CASE 0.57 g Part 14 1 CASE 0.57 g Part 1 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 2 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 3 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 4 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 5 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 6 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 7 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 8 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 9 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 10 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 11 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 12 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 13 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Part 14 of 14 ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING 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) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) TRIDECYL STEARATE (UNII: A8OE252M6L) 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) Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C RED NO. 21 (UNII: 08744Z6JNY) aluminum oxide (UNII: LMI26O6933) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) D&C RED NO. 7 (UNII: ECW0LZ41X8) D&C RED NO. 27 (UNII: 2LRS185U6K) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TALC (UNII: 7SEV7J4R1U) CARMINIC ACID (UNII: CID8Z8N95N) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.57 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 04/03/2014 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-061, 13537-064, 13537-065, 13537-066, 13537-067, 13537-068, 13537-069, 13537-070, 13537-071, 13537-072, 13537-073, 13537-074, 13537-075, 13537-076, 13537-077)