ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MARRON TOSCANA) - BROWN- octinoxate lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD PIMIENTA CALIENTE) - BROWN- octinoxate lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD VINO CAUTIVANTE) - RED- octinoxate lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD ROSA VIVA) - PINK ....... ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED (octinoxate) lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - RED (octinoxate) lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE (octinoxate) lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit [Ventura Corporation LTD] ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD CIRUELA GLAM) - RED- octinoxate lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD FRAMBUESA ENCANTO) - RED- octinoxate lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 (HD MAGENTA SWEET) - PURPLE- octinoxate lipstick ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20- octinoxate kit

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20 by

Drug Labeling and Warnings

ESIKA 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 (6.8%)

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 this product in this container form excesive 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.

May contain:

IRON OXIDES, MICA, TITANIUM DIOXIDE, YELLOW 5 LAKE, RED 30 LAKE, RED 7 LAKE, RED 27 LAKE, CALCIUM ALUMINUM BOROSILICATE, RED 6 LAKE, CARMINE, TIN OXIDE, TALC

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD MARRÓN TOSCANA) - BROWN

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (HD DURAZNO NUDE) - PINK

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

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

ésika

HD COLOR
High Definition Color
LIPSTICK SPF 20

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - Kit Carton

HD COLOR
HIGH DEFINITION COLOR LIPSTICK
SPF 20

ésika

Net Weight
0.275 oz. e (7.8 g)

INGREDIENTS AND APPEARANCE

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   (HD MARRON TOSCANA) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-001
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-001-02	1 in 1 BOX
1	NDC: 13537-001-01	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-002
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-002-04	1 in 1 BOX
1	NDC: 13537-002-03	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-003
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-003-06	1 in 1 BOX
1	NDC: 13537-003-05	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-004
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-004-08	1 in 1 BOX
1	NDC: 13537-004-07	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-005
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-005-10	1 in 1 BOX
1	NDC: 13537-005-09	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-006
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-006-12	1 in 1 BOX
1	NDC: 13537-006-11	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-007
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-007-14	1 in 1 BOX
1	NDC: 13537-007-13	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-008
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-008-16	1 in 1 BOX
1	NDC: 13537-008-15	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	04/03/2014

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   (HD DURAZNO NUDE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-009
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-009-18	1 in 1 BOX
1	NDC: 13537-009-17	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	04/03/2014

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   (HD NARANJA PROVOCACION) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-016
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-016-20	1 in 1 BOX
1	NDC: 13537-016-19	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-017
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-017-22	1 in 1 BOX
1	NDC: 13537-017-21	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-018
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-018-24	1 in 1 BOX
1	NDC: 13537-018-23	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-024
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-024-26	1 in 1 BOX
1	NDC: 13537-024-25	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-030
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-030-28	1 in 1 BOX
1	NDC: 13537-030-27	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	04/03/2014

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-029
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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-029-28	1 in 1 BOX
1	NDC: 13537-029-27	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	04/03/2014

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20  
octinoxate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-236

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-236-32	2 in 1 CARTON
1	NDC: 13537-236-31	1 in 1 TUBE

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	7.8 g
Part 2	1 TUBE	7.8 g
Part 3	1 TUBE	7.8 g
Part 4	1 TUBE	7.8 g
Part 5	1 TUBE	7.8 g
Part 6	1 TUBE	7.8 g
Part 7	1 TUBE	7.8 g
Part 8	1 TUBE	7.8 g
Part 9	1 TUBE	7.8 g
Part 10	1 TUBE	7.8 g
Part 11	1 TUBE	7.8 g
Part 12	1 TUBE	7.8 g

Part 1 of 12

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   HD MARRON TOSCANA - 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 2 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 3 of 12

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   HD VINO CAUTIVANTE - 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 4 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 5 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 6 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 7 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 8 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 9 of 12

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   HD DURAZNO NUDE - 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 10 of 12

ESIKA HD COLOR HIGH DEFINITION COLOR SPF 20   HD NARANJA PROVOCACION - 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 11 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Part 12 of 12

ESIKA 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 3 (UNII: 4370DF050B)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
D&C RED NO. 6 (UNII: 481744AI4O)
STANNIC OXIDE (UNII: KM7N50LOS6)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.8 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	05/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	05/15/2015

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-001, 13537-002, 13537-003, 13537-004, 13537-005, 13537-006, 13537-007, 13537-008, 13537-009, 13537-016, 13537-017, 13537-018, 13537-024, 13537-030, 13537-029, 13537-236)