DailyMed - ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FUCSIA) - PURPLE- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CEREZA) - RED- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (ROSA) - RED- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (RUBI) - RED- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (AMBAR) - BROWN- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FRESA) - RED- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CHAMPAGE) - BEIGE- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (COBRE) - ORANGE- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (PIMIENTA CALIENTE) - BROWN- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (DIAMANTE ROSA) - PINK- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (MELON) - PINK- octinoxate lipstick ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (VINO)

Contains inactivated NDC Code(s)
NDC Code(s): 13537-652-01, 13537-652-02, 13537-653-03, 13537-653-04, view more
13537-654-05, 13537-654-06, 13537-655-07, 13537-655-08, 13537-656-09, 13537-656-10, 13537-657-11, 13537-657-12, 13537-658-13, 13537-658-14, 13537-659-15, 13537-659-16, 13537-660-17, 13537-660-18, 13537-661-19, 13537-661-20, 13537-662-21, 13537-662-22, 13537-663-23, 13537-663-24
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 March 26, 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

LIPSTICK

DIISOPROPYL DIMER DILINOLEATE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYL PALMITATE, TRIDECYL TRIMELLITATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, SYNTHETIC BEESWAX, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, SILICA SILYLATE, PHENOXYETHANOL, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BETA-SITOSTEROL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, DIMETHICONE, FRAGRANCE, CERAMIDE 3, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TRIMETHYLSILOXYSILICATE.

GLOSS

OCTYLDODECANOL, TRIDECYL TRIMELLITATE, POLYETHYLENE, OZOKERITE, PARAFFIN, COPERNICIA CERIFERA (CARNAUBA) WAX, PHENOXYETHANOL, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TOCOPHERYL ACETATE, DIMETHICONE, FRAGRANCE, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE.

MAY CONTAIN

SYNTHETIC FLUORPHLOGOPITE, RED 21 LAKE, MICA, IRON OXIDES, CALCIUM SODIUM BOROSILICATE, YELLOW 5 LAKE, TITANIUM DIOXIDE, RED 27 LAKE, RED 7 LAKE, TALC, SILICA, RED 30 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, TIN OXIDE, BLUE 1 LAKE.
SPL UNCLASSIFIED SECTION

Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (FUCSIA) - PURPLE

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (CEREZA) - RED

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (ROSA) - RED

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (RUBI) - RED

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (AMBAR) - BROWN

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (FRESA) - RED

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (CHAMPAGE) - BEIGE

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (COBRE) - ORANGE

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (PIMIENTA CALIENTE) - BROWN

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (DIAMANTE ROSA) - PINK

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (MELON) - PINK

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)
PRINCIPAL DISPLAY PANEL - 3.8 g Tube Box - (VINO) - BROWN

ésika
PRO

MULTI-GLOSS
LIPSTICK

Dual lipstick with
triple gloss
effect SPF 15

Net Weigth
0.13 oz. e (3.8g)

INGREDIENTS AND APPEARANCE

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FUCSIA) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-652
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-652-02	1 in 1 BOX
1	NDC:13537-652-01	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CEREZA) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-653
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-653-04	1 in 1 BOX
1	NDC:13537-653-03	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (ROSA) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-654
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-654-06	1 in 1 BOX
1	NDC:13537-654-05	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (RUBI) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-655
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-655-08	1 in 1 BOX
1	NDC:13537-655-07	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (AMBAR) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-656
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-656-10	1 in 1 BOX
1	NDC:13537-656-09	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FRESA) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-657
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-657-12	1 in 1 BOX
1	NDC:13537-657-11	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CHAMPAGE) - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-658
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-658-14	1 in 1 BOX
1	NDC:13537-658-13	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (COBRE) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-659
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-659-16	1 in 1 BOX
1	NDC:13537-659-15	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (PIMIENTA CALIENTE) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-660
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-660-18	1 in 1 BOX
1	NDC:13537-660-17	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (DIAMANTE ROSA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-661
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-661-20	1 in 1 BOX
1	NDC:13537-661-19	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (MELON) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-662
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-662-22	1 in 1 BOX
1	NDC:13537-662-21	3.8 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	03/26/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (VINO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-663
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
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
OCTYLDODECANOL (UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
CANDELILLA WAX (UNII: WL0328HX19)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CERAMIDE 3 (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PARAFFIN (UNII: I9O0E3H2ZE)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 30 (UNII: 2S42T2808B)
STANNIC OXIDE (UNII: KM7N50LOS6)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description
Packaging
1	NDC:13537-663-24	1 in 1 BOX
1	NDC:13537-663-23	3.8 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	03/26/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-652, 13537-653, 13537-654, 13537-655, 13537-656, 13537-657, 13537-658, 13537-659, 13537-660, 13537-661, 13537-662, 13537-663)

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	NDC
1	13537-652-01
2	13537-652-02 (inactivated)
3	13537-653-03
4	13537-653-04 (inactivated)
5	13537-654-05
6	13537-654-06 (inactivated)
7	13537-655-07
8	13537-655-08 (inactivated)
9	13537-656-09
10	13537-656-10 (inactivated)
11	13537-657-11
12	13537-657-12 (inactivated)
13	13537-658-13
14	13537-658-14 (inactivated)
15	13537-659-15
16	13537-659-16 (inactivated)
17	13537-660-17
18	13537-660-18 (inactivated)
19	13537-661-19
20	13537-661-20 (inactivated)
21	13537-662-21
22	13537-662-22 (inactivated)
23	13537-663-23
24	13537-663-24 (inactivated)

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