DailyMed - ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON HAVANA) - BROWN- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (NATURAL DUNE) - PINK- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON FANATIC) - RED- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROJO FIESTA) - RED- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON BAMBU) - BROWN- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA DELIRIO) - PINK- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROJO PASION) - RED- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA SUBLIME) - PINK- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROSA FIORELLE) - PINK- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (NARANJA OBSESION) - ORANGE- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (BORGONA SWEET) - PINK- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (VINO DESEO) - PURPLE- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA TENTACION) - PINK- octinoxate lipstick ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20- octinoxate kit

Contains inactivated NDC Code(s)
NDC Code(s): 13537-638-01, 13537-638-02, 13537-639-03, 13537-639-04, view more
13537-640-05, 13537-640-06, 13537-642-07, 13537-642-08, 13537-643-09, 13537-643-10, 13537-644-11, 13537-644-12, 13537-645-13, 13537-645-14, 13537-646-15, 13537-646-16, 13537-647-17, 13537-647-18, 13537-648-19, 13537-648-20, 13537-649-21, 13537-649-22, 13537-650-23, 13537-650-24, 13537-651-25, 13537-651-26, 13537-688-27, 13537-688-28
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 April 17, 2015

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: 7.00%
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.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- 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

DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, ETHYLHEXYL PALMITATE, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, OZOKERITE, POLYMETHYL METHACRYLATE, TRIDECYL STEARATE, POLYGLYCERYL-3 DIISOSTEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, SYNTHETIC BEESWAX, TOCOPHERYL ACETATE, PHENOXYETHANOL, CERAMIDE 3, CAPRYLYL GLYCOL, CHLORPHENESIN, FRAGRANCE.

MAY CONTAIN :

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

Dist. by Ventura Corp,
Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON HAVANA) - BROWN

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NATURAL DUNE) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON FANATIC) - RED

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO FIESTA) - RED

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (MARRON BAMBU) - BROWN

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA DELIRIO) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROJO PASION) - RED

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA SUBLIME) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (ROSA FIORELLE) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (NARANJA OBSESION) - ORANGE

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (BORGOÑA SWEET) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (VINO DESEO) - PURPLE

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - (FUCSIA TENTACION) - PINK

ésika
PRO

ADVANCE LASTING
LIPSTICK
Long-lasting and
comfort lipstick
SPF 20

Net Weigth
0.14 oz. e (4g)
PRINCIPAL DISPLAY PANEL - Kit Carton

ADVANCE
LASTING LIPSTICK
LONG-LASTING AND COMFORT LIPSTICK SPF 20

ésika
PRO

Net Weight 0.24 oz. e (6.8 g.)

INGREDIENTS AND APPEARANCE

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON HAVANA) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-638
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-638-02	1 in 1 BOX
1	NDC:13537-638-01	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (NATURAL DUNE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-639
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-639-04	1 in 1 BOX
1	NDC:13537-639-03	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON FANATIC) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-640
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-640-06	1 in 1 BOX
1	NDC:13537-640-05	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROJO FIESTA) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-642
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-642-08	1 in 1 BOX
1	NDC:13537-642-07	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON BAMBU) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-643
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-643-10	1 in 1 BOX
1	NDC:13537-643-09	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA DELIRIO) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-644
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-644-12	1 in 1 BOX
1	NDC:13537-644-11	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROJO PASION) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-645
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-645-14	1 in 1 BOX
1	NDC:13537-645-13	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA SUBLIME) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-646
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-646-16	1 in 1 BOX
1	NDC:13537-646-15	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROSA FIORELLE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-647
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-647-18	1 in 1 BOX
1	NDC:13537-647-17	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (NARANJA OBSESION) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-648
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-648-20	1 in 1 BOX
1	NDC:13537-648-19	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (BORGONA SWEET) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-649
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-649-22	1 in 1 BOX
1	NDC:13537-649-21	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (VINO DESEO) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-650
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-650-24	1 in 1 BOX
1	NDC:13537-650-23	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA TENTACION) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-651
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-651-26	1 in 1 BOX
1	NDC:13537-651-25	4 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20
octinoxate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-688

#	Item Code	Package Description
Packaging
1	NDC:13537-688-28	2 in 1 CARTON
1	NDC:13537-688-27	1 in 1 TUBE

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	6.8 g
Part 2	1 TUBE	6.8 g
Part 3	1 TUBE	6.8 g
Part 4	1 TUBE	6.8 g
Part 5	1 TUBE	6.8 g
Part 6	1 TUBE	6.8 g
Part 7	1 TUBE	6.8 g
Part 8	1 TUBE	6.8 g
Part 9	1 TUBE	6.8 g
Part 10	1 TUBE	6.8 g
Part 11	1 TUBE	6.8 g
Part 12	1 TUBE	6.8 g

Part 1 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON HAVANA) - BROWN
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 2 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (NATURAL DUNE) - PINK
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 3 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON FANATIC) - RED
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 4 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROJO FIESTA) - RED
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 5 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (MARRON BAMBU) - BROWN
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 6 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA DELIRIO) - PINK
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 7 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROJO PASION) - RED
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 8 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA SUBLIME) - PINK
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 9 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (ROSA FIORELLE) - PINK
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 10 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (BORGONA SWEET) - PINK
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 11 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (VINO DESEO) - PURPLE
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Part 12 of 12

ESIKA PRO ADVANCE LASTING LONG-LASTING AND COMFORT SPF 20 (FUCSIA TENTACION) - PINK
octinoxate lipstick

Product Information
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.07 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
TRIDECYL STEARATE (UNII: A8OE252M6L)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CERAMIDE 3 (UNII: 4370DF050B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
MANGANESE VIOLET (UNII: 72M48QQV8Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		6.8 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	04/17/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	04/17/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-638, 13537-639, 13537-640, 13537-642, 13537-643, 13537-644, 13537-645, 13537-646, 13537-647, 13537-648, 13537-649, 13537-650, 13537-651, 13537-688)

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	NDC
1	13537-638-01
2	13537-638-02 (inactivated)
3	13537-639-03
4	13537-639-04 (inactivated)
5	13537-640-05
6	13537-640-06 (inactivated)
7	13537-642-07
8	13537-642-08 (inactivated)
9	13537-643-09
10	13537-643-10 (inactivated)
11	13537-644-11
12	13537-644-12 (inactivated)
13	13537-645-13
14	13537-645-14 (inactivated)
15	13537-646-15
16	13537-646-16 (inactivated)
17	13537-647-17
18	13537-647-18 (inactivated)
19	13537-648-19
20	13537-648-20 (inactivated)
21	13537-649-21
22	13537-649-22 (inactivated)
23	13537-650-23
24	13537-650-24 (inactivated)
25	13537-651-25
26	13537-651-26 (inactivated)
27	13537-688-27
28	13537-688-28 (inactivated)

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Number of versions: 1

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