DailyMed - 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

Contains inactivated NDC Code(s)
NDC Code(s): 43596-0023-1, 43596-0023-2, 43596-0024-1, 43596-0024-2, view more
43596-0025-1, 43596-0025-2, 43596-0026-1, 43596-0026-2, 43596-0027-1, 43596-0027-2, 43596-0028-1, 43596-0028-2, 43596-0029-1, 43596-0029-2, 43596-0030-1, 43596-0030-2, 43596-0031-1, 43596-0031-2, 43596-0032-1, 43596-0032-2, 43596-0033-1, 43596-0033-2, 43596-0034-1, 43596-0034-2, 43596-0035-1, 43596-0035-2, 43596-0036-1, 43596-0036-2, 43596-0037-1, 43596-0037-2, 43596-0048-1, 43596-0048-2, 43596-0049-1, 43596-0049-2, 43596-0050-1, 43596-0050-2, 43596-0051-1, 43596-0051-2, 43596-0052-1, 43596-0052-2, 43596-0053-1, 43596-0053-2, 43596-0053-3
Packager: Ventura Corporation LTD

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 7, 2017

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

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

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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	NDC
1	43596-0023-1
2	43596-0023-2 (inactivated)
3	43596-0024-1
4	43596-0024-2 (inactivated)
5	43596-0025-1
6	43596-0025-2 (inactivated)
7	43596-0026-1
8	43596-0026-2 (inactivated)
9	43596-0027-1
10	43596-0027-2 (inactivated)
11	43596-0028-1
12	43596-0028-2 (inactivated)
13	43596-0029-1
14	43596-0029-2 (inactivated)
15	43596-0030-1
16	43596-0030-2 (inactivated)
17	43596-0031-1
18	43596-0031-2 (inactivated)
19	43596-0032-1
20	43596-0032-2 (inactivated)
21	43596-0033-1
22	43596-0033-2 (inactivated)
23	43596-0034-1
24	43596-0034-2 (inactivated)
25	43596-0035-1
26	43596-0035-2 (inactivated)
27	43596-0036-1
28	43596-0036-2 (inactivated)
29	43596-0037-1
30	43596-0037-2 (inactivated)
31	43596-0048-1
32	43596-0048-2 (inactivated)
33	43596-0049-1
34	43596-0049-2 (inactivated)
35	43596-0050-1
36	43596-0050-2 (inactivated)
37	43596-0051-1
38	43596-0051-2 (inactivated)
39	43596-0052-1
40	43596-0052-2 (inactivated)
41	43596-0053-1
42	43596-0053-2
43	43596-0053-3 (inactivated)

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Number of versions: 1

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.