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 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROJO LUJURIA) - RED- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (CORAL CHIC) - PINK- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ENCANTO) - PINK- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (BORGONA SEXY) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FUCSIA CAUTIVANTE) - PINK- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (GRANATE SEDUCTOR) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA ROMANTICA) - PINK- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (NARANJA PRIMAVERA) - ORANGE- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (FRAMBUESA MANIA) - RED- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (ROSA DULZURA) - PINK- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25  (PIMIENTA CALIENTE) - BROWN- octinoxate and oxybenzone lipstick 
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25- octinoxate and oxybenzone 
Ventura Corporation LTD

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.

----------

ésika HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING LIPSTICK SPF 25

Drug Facts

Active Ingredients

OCTINOXATE: 6.64%
OXYBENZONE: 1.51%

Purpose

Sunscreen

Uses

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.

  • Do not use on damaged or broken skin.

  • When using this product keep out of eyes.Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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).

P.R.: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON GLAMOUR) - BROWN

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (MARRON GLAMOUR) - BROWN

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO DESEO) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (ROJO DESEO) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO INTRIGANTE) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (ROJO INTRIGANTE) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO LUJURIA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (ROJO LUJURIA) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (CORAL CHIC) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (CORAL CHIC) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ENCANTO) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (ROSA ENCANTO) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGOÑA SEXY) - PURPLE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (BORGOÑA SEXY) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (FUCSIA CAUTIVANTE) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (GRANATE SEDUCTOR) - PURPLE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA ROMÁNTICA) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (ROSA ROMÁNTICA) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (NARANJA PRIMAVERA) - ORANGE

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FRAMBUESA MANÍA) - RED

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (FRAMBUESA MANÍA) - RED

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA DULZURA) - PINK

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (ROSA DULZURA) - PINK

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN

ésika

HYDRACOLOR 2 in 1
Highly moisturizing and coloring
LIPSTICK SPF 25

4 g e (.14 oz.)

Principal Display Panel - 4 g Tube Box - (PIMIENTA CALIENTE) - BROWN

PRINCIPAL DISPLAY PANEL - 14 Tube Kit

HYDRACOLOR 2 in 1
Highly moisturizing
and coloring LIPSTICK SPF 25

ésika

8 g e (.28 oz.)

Principal Display Panel - 14 Tube Kit
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-061-021 in 1 BOX
1NDC:13537-061-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO DESEO) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-064-041 in 1 BOX
1NDC:13537-064-034 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-065-061 in 1 BOX
1NDC:13537-065-054 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-066-081 in 1 BOX
1NDC:13537-066-074 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-067-101 in 1 BOX
1NDC:13537-067-094 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-068-121 in 1 BOX
1NDC:13537-068-114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (BORGONA SEXY) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-069-141 in 1 BOX
1NDC:13537-069-134 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA CAUTIVANTE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-070-161 in 1 BOX
1NDC:13537-070-154 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-071-181 in 1 BOX
1NDC:13537-071-174 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-072
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-072-201 in 1 BOX
1NDC:13537-072-194 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (NARANJA PRIMAVERA) - ORANGE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-073-221 in 1 BOX
1NDC:13537-073-214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-074-241 in 1 BOX
1NDC:13537-074-234 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-075-261 in 1 BOX
1NDC:13537-075-254 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-076-281 in 1 BOX
1NDC:13537-076-274 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 
octinoxate and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-077
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-077-291 in 1 CASE
2NDC:13537-077-301 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 CASE 0.57 g
Part 21 CASE 0.57 g
Part 31 CASE 0.57 g
Part 41 CASE 0.57 g
Part 51 CASE 0.57 g
Part 61 CASE 0.57 g
Part 71 CASE 0.57 g
Part 81 CASE 0.57 g
Part 91 CASE 0.57 g
Part 101 CASE 0.57 g
Part 111 CASE 0.57 g
Part 121 CASE 0.57 g
Part 131 CASE 0.57 g
Part 141 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 lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 2 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO DESEO) - RED
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 3 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 4 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 5 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 6 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 7 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (BORGONA SEXY) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 8 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FUCSIA CAUTIVANTE) - PINK
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 9 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 10 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 11 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (NARANJA PRIMAVERA) - ORANGE
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 12 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 13 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Part 14 of 14
ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25   (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.0664 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.0151 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
10.57 g in 1 CASE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/03/2014
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(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)

Revised: 4/2014
Document Id: 1c92023a-0e67-4952-9c17-fdd98467bab6
Set id: 8a2c117b-0849-4c99-9683-2de66d35165c
Version: 1
Effective Time: 20140415
 
Ventura Corporation LTD