ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN- octinoxate lipstick ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - BROWN- octinoxate lipstick ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK- octinoxate lipstick ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CORAL EN .......SIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD BERRY BALCANIC) - RED- octinoxate lipstick ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA OBSESSION) - PINK- octinoxate lipstick ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROJO EXHUBERANTE) - RED- octinoxate lipstick ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 by

Drug Labeling and Warnings

ESIKA PRO HD COLOR 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 6.80%

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, octyldodecanol, caprylic/capric triglyceride, polyethylene, tridecyl trimellitate, castor isostearate beeswax succinate, polyglyceryl-3 diisostearate, isopropyl lanolate, copernicia cerifera (carnauba) wax, mica, microcrystalline wax, diisostearyl malate, glyceryl isostearate, isostearyl alcohol, butyrospermum parkii (shea) butter, phenoxyethanol, beta-sitosterol, phenyl trimethicone, silica, silica silylate, euphorbia cerifera (candelilla) wax, fragrance, caprylyl glycol, dimethicone, chlorphenesin, ceramide 3, tocopheryl acetate, oleyl alcohol, trimethylsiloxysilicate, benzimidazole diamond amidoethyl urea carbamoyl propyl polymethylsilsesquioxane, dioleyl tocopheryl methylsilanol, alpha-isomethyl ionone, d-limonene, linalool, amyl cinnamal, citronellol. May contain: titanium dioxide, mica, iron oxides, red 30 lake, red 27 lake, red 7 lake, yellow 5 lake, red 21 lake, talc, calcium aluminum borosilicate, blue 1 lake, hydrogenated polyisobutene, carmine, palmitic acid, tin oxide

SPL UNCLASSIFIED SECTION

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

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD VINO CAUTIVANTE) - BROWN

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD CORAL ENSUENO) - RED

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD CAFE HABANO) - BROWN

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD MELON INTENSE) - PINK

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD CIRUELA GLAM) - RED

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD FRAMBUESA ENCANTO) - PURPLE

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD MAGENTA SWEET) - PURPLE

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD LAVA LIPS) - ORANGE

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD FRESA IMPERIAL) - RED

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD BERRY BALCANIC) - RED

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

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

HD COLOR
High Definition Color
Lipstick SPF 20

Net Weight 0.14 oz. e (4 g)

ésika
PRO

PRINCIPAL DISPLAY PANEL - Kit Carton

HD COLOR
HIGH DEFINITION COLOR LIPSTICK
SPF 20

ésika
PRO

Net Weight
0.275 oz. e (7.8 g)

INGREDIENTS AND APPEARANCE

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-729
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-729-02	1 in 1 BOX	02/29/2016
1	NDC: 13537-729-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD VINO CAUTIVANTE) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-730
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-730-04	1 in 1 BOX	02/29/2016
1	NDC: 13537-730-03	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSA VIVA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-731
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-731-06	1 in 1 BOX	02/29/2016
1	NDC: 13537-731-05	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CORAL ENSUENO) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-732
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-732-08	1 in 1 BOX	02/29/2016
1	NDC: 13537-732-07	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROJO GLAM) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-733
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-733-10	1 in 1 BOX	02/29/2016
1	NDC: 13537-733-09	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CAFE HABANO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-734
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-734-12	1 in 1 BOX	02/29/2016
1	NDC: 13537-734-11	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-735
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-735-14	1 in 1 BOX	02/29/2016
1	NDC: 13537-735-13	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MELON INTENSE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-736
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-736-16	1 in 1 BOX	02/29/2016
1	NDC: 13537-736-15	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSADO CHIC) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-737
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-737-18	1 in 1 BOX	02/29/2016
1	NDC: 13537-737-17	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CIRUELA GLAM) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-738
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-738-20	1 in 1 BOX	02/29/2016
1	NDC: 13537-738-19	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FRAMBUESA ENCANTO) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-739
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-739-22	1 in 1 BOX	02/29/2016
1	NDC: 13537-739-21	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MAGENTA SWEET) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-740
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-740-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-740-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD LAVA LIPS) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-741
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-741-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-741-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FRESA IMPERIAL) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-742
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-742-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-742-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FUCSIA OPULENTO) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-743
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-743-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-743-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD BERRY BALCANIC) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-744
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-744-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-744-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSA OBSESSION) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-745
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-745-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-745-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROJO EXHUBERANTE) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-746
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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-746-24	1 in 1 BOX	02/29/2016
1	NDC: 13537-746-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	02/29/2016

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20 
octinoxate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-747

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-747-28	1 in 1 KIT	02/29/2016	12/01/2018
1	NDC: 13537-747-27	1 in 1 BOX

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	0.43 g
Part 2	1 TUBE	0.43 g
Part 3	1 TUBE	0.43 g
Part 4	1 TUBE	0.43 g
Part 5	1 TUBE	0.43 g
Part 6	1 TUBE	0.43 g
Part 7	1 TUBE	0.43 g
Part 8	1 TUBE	0.43 g
Part 9	1 TUBE	0.43 g
Part 10	1 TUBE	0.43 g
Part 11	1 TUBE	0.43 g
Part 12	1 TUBE	0.43 g
Part 13	1 TUBE	0.43 g
Part 14	1 TUBE	0.43 g
Part 15	1 TUBE	0.43 g
Part 16	1 TUBE	0.43 g
Part 17	1 TUBE	0.43 g
Part 18	1 TUBE	0.43 g

Part 1 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD PIMIENTA CALIENTE) - BROWN
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 2 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD VINO CAUTIVANTE) - BROWN
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 3 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSA VIVA) - PINK
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 4 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CORAL ENSUENO) - RED
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 5 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROJO GLAM) - RED
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 6 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CAFE HABANO) - BROWN
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 7 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FUCSIA VIBRANTE) - PINK
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 8 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MELON INTENSE) - PINK
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 9 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSADO CHIC) - PINK
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 10 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD CIRUELA GLAM) - RED
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 11 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FRAMBUESA ENCANTO) - PURPLE
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 12 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MAGENTA SWEET) - PURPLE
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 13 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD LAVA LIPS) - ORANGE
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 14 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FRESA IMPERIAL) - RED
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 15 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD FUCSIA OPULENTO) - PINK
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 16 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD BERRY BALCANIC) - RED
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 17 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROSA OBSESSION) - PINK
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Part 18 of 18

ESIKA PRO HD COLOR HIGH DEFINITION COLOR SPF 20   (HD ROJO EXHUBERANTE) - RED
octinoxate lipstick

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)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
PALMITIC ACID (UNII: 2V16EO95H1)
STANNIC OXIDE (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		0.43 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	02/29/2016	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/29/2016	12/01/2018

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-729, 13537-730, 13537-731, 13537-732, 13537-733, 13537-734, 13537-735, 13537-736, 13537-737, 13537-738, 13537-739, 13537-740, 13537-741, 13537-742, 13537-743, 13537-744, 13537-745, 13537-746, 13537-747)