DailyMed - ESIKA PRO PERFECT MATCH VOLUMEN (FRESA TENTACION) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (CAFE MISTERIO) - BROWN- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (ROSA DESEO) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (DURAZNO AMOR) - ORANGE- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (ROSA GOLOSA) - PINK- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (CORAL SEDUCTOR) - PINK- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (CEREZA SEXY) - PINK- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (FUCSIA SENSUAL) - PINK- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (ROJO PASION) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (VINO CALIENTE) - PURPLE- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (PIMIENTA CALIENTE) - BROWN- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (CAFE PARISO) - BROWN- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (ROSE BLOOM) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (FRESA ENERGY) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (BURGUNDY VITAL) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (VINO SUBLIME) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN (ROJO RADIANT)

Contains inactivated NDC Code(s)
NDC Code(s): 13537-180-01, 13537-180-02, 13537-181-03, 13537-181-04, view more
13537-182-05, 13537-182-06, 13537-183-07, 13537-183-08, 13537-184-09, 13537-184-10, 13537-185-11, 13537-185-12, 13537-186-13, 13537-186-14, 13537-302-15, 13537-302-16, 13537-304-17, 13537-304-18, 13537-480-19, 13537-480-20, 13537-481-21, 13537-481-22, 13537-761-01, 13537-761-02, 13537-762-01, 13537-762-02, 13537-763-01, 13537-763-02, 13537-764-01, 13537-764-02, 13537-765-01, 13537-765-02, 13537-766-01, 13537-766-02
Packager: Ventura Corporation LTD

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

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

Drug Label Information

Updated October 4, 2017

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

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

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

OCTINOXATE 7.50 %
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

LIPSTICK

DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SYNTHETIC BEESWAX, POLYETHYLENE, TRIDECYL STEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, POLYGLYCERYL-3 DIISOSTEARATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, HYDROGENATED VEGETABLE OIL, SILICA DIMETHYL SILYLATE, PHENOXYETHANOL, CETEARYL ETHYLHEXANOATE, GLYCERIN, FRAGRANCE, CAPRYLYL GLYCOL, CHLORPHENESIN, CERAMIDE 3, SODIUM SACCHARIN, SORBITAN ISOSTEARATE, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, PORTULACA PILOSA EXTRACT, SUCROSE COCOATE, PALMITOYL TRIPEPTIDE-38, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.

MAY CONTAIN :

IRON OXIDES, MANGANESE VIOLET, MICA, RED 30 LAKE, TITANIUM DIOXIDE, RED 21 LAKE, YELLOW 5 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE.
INGREDIENTS

LIP LINER

ISODODECANE, DIMETHICONE, TRIMETHYLSILOXYSILICATE, CYCLOPENTASILOXANE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, PHENOXYETHANOL, FRAGRANCE, CAPRYLYL GLYCOL, CHLORPHENESIN, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL.

MAY CONTAIN :

IRON OXIDES, MANGANESE VIOLET, TITANIUM DIOXIDE, RED 7 LAKE, RED 40 LAKE, MICA, RED 27 LAKE, YELLOW 5 LAKE, RED 21 LAKE, BLUE 1 LAKE, TALC.
SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FRESA TENTACION) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CAFE MISTERIO) - BROWN

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROSA DESEO) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (DURAZNO AMOR) - ORANGE

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROSA GOLOSA) - PINK

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CORAL SEDUCTOR) - PINK

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CEREZA SEXY) - PINK

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FUCSIA SENSUAL) - PINK

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROJO PASION) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (VINO CALIENTE) - PURPLE

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (PIMIENTA CALIENTE) - BROWN

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (CAFÉ PARISO) - BROWN

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROSE BLOOM) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FRESA ENERGY) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (BURGUNDY VITAL) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (VINO SUBLIME) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (ROJO RADIANT) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

Lipstick: Net Wt. 0.077 oz. e (2,2 g) / Lip liner: 3 ml e (0.10 fl.oz.)

INGREDIENTS AND APPEARANCE

ESIKA PRO PERFECT MATCH VOLUMEN (FRESA TENTACION) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-180
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-180-02	1 in 1 BOX	07/10/2015
1	NDC:13537-180-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (CAFE MISTERIO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-181
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-181-04	1 in 1 BOX	07/10/2015
1	NDC:13537-181-03	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (ROSA DESEO) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-182
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-182-06	1 in 1 BOX	07/10/2015
1	NDC:13537-182-05	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (DURAZNO AMOR) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-183
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-183-08	1 in 1 BOX	07/10/2015
1	NDC:13537-183-07	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (ROSA GOLOSA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-184
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-184-10	1 in 1 BOX	07/10/2015
1	NDC:13537-184-09	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (CORAL SEDUCTOR) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-185
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-185-12	1 in 1 BOX	07/10/2015
1	NDC:13537-185-11	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (CEREZA SEXY) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-186
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-186-14	1 in 1 BOX	07/10/2015
1	NDC:13537-186-13	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (FUCSIA SENSUAL) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-302
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-302-16	1 in 1 BOX	07/10/2015
1	NDC:13537-302-15	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (ROJO PASION) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-304
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-304-18	1 in 1 BOX	07/10/2015
1	NDC:13537-304-17	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (VINO CALIENTE) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-480
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-480-20	1 in 1 BOX	07/10/2015
1	NDC:13537-480-19	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (PIMIENTA CALIENTE) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-481
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-481-22	1 in 1 BOX	07/10/2015
1	NDC:13537-481-21	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (CAFE PARISO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-761
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-761-02	1 in 1 BOX	07/10/2015
1	NDC:13537-761-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (ROSE BLOOM) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-762
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-762-02	1 in 1 BOX	07/10/2015
1	NDC:13537-762-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (FRESA ENERGY) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-763
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-763-02	1 in 1 BOX	07/10/2015
1	NDC:13537-763-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (BURGUNDY VITAL) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-764
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-764-02	1 in 1 BOX	07/10/2015
1	NDC:13537-764-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (VINO SUBLIME) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-765
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-765-02	1 in 1 BOX	07/10/2015
1	NDC:13537-765-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

ESIKA PRO PERFECT MATCH VOLUMEN (ROJO RADIANT) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-766
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECYL STEARATE (UNII: A8OE252M6L)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
SHEA BUTTER (UNII: K49155WL9Y)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SUCROSE COCOATE (UNII: 3H18P0UK73)
PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
MICA (UNII: V8A1AW0880)
D&C RED NO. 30 (UNII: 2S42T2808B)
ALUMINUM OXIDE (UNII: LMI26O6933)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-766-02	1 in 1 BOX	07/10/2015
1	NDC:13537-766-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	07/10/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-180, 13537-181, 13537-182, 13537-183, 13537-184, 13537-185, 13537-186, 13537-302, 13537-304, 13537-480, 13537-481, 13537-761, 13537-762, 13537-763, 13537-764, 13537-765, 13537-766)

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Published Date (What is this?)	Version	Files
Oct 10, 2017	2 (current)	download
Jul 14, 2015	1	download

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	NDC
1	13537-180-01
2	13537-180-02 (inactivated)
3	13537-181-03
4	13537-181-04 (inactivated)
5	13537-182-05
6	13537-182-06 (inactivated)
7	13537-183-07
8	13537-183-08 (inactivated)
9	13537-184-09
10	13537-184-10 (inactivated)
11	13537-185-11
12	13537-185-12 (inactivated)
13	13537-186-13
14	13537-186-14 (inactivated)
15	13537-302-15
16	13537-302-16 (inactivated)
17	13537-304-17
18	13537-304-18 (inactivated)
19	13537-480-19
20	13537-480-20 (inactivated)
21	13537-481-21
22	13537-481-22 (inactivated)
23	13537-761-01
24	13537-761-02 (inactivated)
25	13537-762-01
26	13537-762-02 (inactivated)
27	13537-763-01
28	13537-763-02 (inactivated)
29	13537-764-01
30	13537-764-02 (inactivated)
31	13537-765-01
32	13537-765-02 (inactivated)
33	13537-766-01
34	13537-766-02 (inactivated)

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