ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 VINO CAUTIVANTE - PURPLE- octinoxate lipstick ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 PIMIENTA CALIENTE - RED- octinoxate lipstick ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 ROJO GLAM - RED- octinoxate lipstick ESIKA PRO HD LONGWEAR LONG-LA .......TION COLOR SPF 20 MARRON HAVANA - BROWN- octinoxate lipstick ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 MARRON FANATIC - BROWN- octinoxate lipstick ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 NUDE ROSE- BEIGE- octinoxate lipstick ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20- octinoxate kit

Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 by

Drug Labeling and Warnings

Esika PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE 6.8%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

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.
• 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

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

DIISOPROPYL DIMER DILINOLEATE, TRIDECYL TRIMELLITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, OCTYLDODECANOL, CASTOR ISOSTEARATE BEESWAX SUCCINATE, ISOPROPYL LANOLATE, POLYGLYCERYL-3 DIISOSTEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, MICROCRYSTALLINE WAX, DIISOSTEARYL MALATE, MICA, ISODODECANE, POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, SILICA, SILICA SILYLATE, HEXYL LAURATE, METHYLPROPANEDIOL, FRAGRANCE, CAPRYLYL GLYCOL, CHLORPHENESIN, CERAMIDE 3, SILANEDIOL SALICYLATE, TOCOPHERYL ACETATE, OLEYL ALCOHOL, DIMETHICONE, TROMETHAMINE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIOLEYL TOCOPHERYL METHYLSILANOL, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL. MAY CONTAIN: IRON OXIDES (CI 77491), TITANIUM DIOXIDE (CI 77891), RED 30 LAKE (CI 73360), MICA (CI 77019), RED 27 LAKE (CI 45410), YELLOW 5 LAKE (CI 19140), RED 21 LAKE (CI 45380), RED 7 LAKE (CI 15850), IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), TALC, BLUE 1 LAKE (CI 42090).

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VINO CAUTIVANTE - PURPLE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO GLAM - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO PASIÓN - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - VINO DESEO - PURPLE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA TENTACIÓN - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA DELIRIO - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA VIVA - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - CORAL ENSUEÑO - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN BAMBÚ - BROWN

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA FIORELLE - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NATURAL DUNE - BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROJO FIESTA - RED

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE CREAM - BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE MOCCHA - BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA SUBLIME - PINK

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN HAVANA - BROWN

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - MARRÓN FANATIC - BROWN

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - NUDE ROSE- BEIGE

ésika
PRO

HD LONGWEAR

Long-lasting
high-definition
color lipstick SPF 20

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - Kit Carton

HD LONGWEAR
LONG-LASTING HIGH-DEFINITION
COLOR LIPSTICK SPF 20

ésika
PRO

Net Wt. 0.24 oz. e (7 g)

INGREDIENTS AND APPEARANCE

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   VINO CAUTIVANTE - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0023-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0023-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   PIMIENTA CALIENTE - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0024-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0024-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROJO GLAM - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0025-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0025-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROJO PASION - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0026-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0026-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   VINO DESEO - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0027-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0027-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   FUCSIA TENTACION - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0028-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0028-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   FUCSIA DELIRIO - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0029
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0029-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0029-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   FUCSIA VIBRANTE - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0030-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0030-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROSA VIVA - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0031
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0031-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0031-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   CORAL ENSUENO - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0032
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0032-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0032-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   MARRON BAMBU - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0033-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0033-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROSA FIORELLE - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0034-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0034-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   NATURAL DUNE - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0035-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0035-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROJO FIESTA - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0036-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0036-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   NUDE CREAM - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0037-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0037-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   NUDE MOCCHA - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0048-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0048-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   FUCSIA SUBLIME - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0049-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0049-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   MARRON HAVANA - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0050-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0050-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   MARRON FANATIC - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0051-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0051-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   NUDE ROSE- BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0052
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0052-2	1 in 1 BOX	01/27/2017
1	NDC: 43596-0052-1	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20 
octinoxate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43596-0053

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43596-0053-3	1 in 1 BOX	01/27/2017
1	NDC: 43596-0053-2	12 in 1 TRAY
1	NDC: 43596-0053-1	1 in 1 CONTAINER

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 CONTAINER	0.5833 g
Part 2	1 CONTAINER	0.5833 g
Part 3	1 CONTAINER	0.5833 g
Part 4	1 CONTAINER	0.5833 g
Part 5	1 CONTAINER	0.5833 g
Part 6	1 CONTAINER	0.5833 g
Part 7	1 CONTAINER	0.5833 g
Part 8	1 CONTAINER	0.5833 g
Part 9	1 CONTAINER	0.5833 g
Part 10	1 CONTAINER	0.5833 g
Part 11	1 CONTAINER	0.5833 g
Part 12	1 CONTAINER	0.5833 g

Part 1 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   VINO CAUTIVANTE - PURPLE
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 2 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   VINO DESEO - PURPLE
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 3 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   MARRON BAMBU - BROWN
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 4 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   NUDE MOCCHA - BEIGE
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 5 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   PIMIENTA CALIENTE - RED
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 6 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROJO FIESTA - RED
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 7 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROJO PASION - RED
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 8 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   CORAL ENSUENO - RED
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 9 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   FUCSIA TENTACION - PINK
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 10 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   FUCSIA DELIRIO - PINK
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 11 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   NUDE ROSE- BEIGE
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Part 12 of 12

ESIKA PRO HD LONGWEAR LONG-LASTING HIGH-DEFINITION COLOR SPF 20   ROSA FIORELLE - PINK
octinoxate paste

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
MICA (UNII: V8A1AW0880)
ISODODECANE (UNII: A8289P68Y2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
DIMETHICONE (UNII: 92RU3N3Y1O)
TROMETHAMINE (UNII: 023C2WHX2V)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ACID RED 87 (UNII: TDQ283MPCW)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.5833 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/27/2017

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0023, 43596-0024, 43596-0025, 43596-0026, 43596-0027, 43596-0028, 43596-0029, 43596-0030, 43596-0031, 43596-0032, 43596-0033, 43596-0034, 43596-0035, 43596-0036, 43596-0037, 43596-0048, 43596-0049, 43596-0050, 43596-0051, 43596-0052, 43596-0053)