DailyMed - ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA GALA MATE - PURPLE- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRAMBUESA GLAM MATE - RED- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA DESEO MATE - PINK- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA PINK MATE - PURPLE- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROJO PASION MATE - RED- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 PIMIENTA CALIENTE MATE - BROWN- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRESA PROFUNDO MATE - RED- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA VIBRANTE MATE - PURPLE- octinoxate lipstick ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA VIVA MATE

Contains inactivated NDC Code(s)
NDC Code(s): 13537-712-01, 13537-712-02, 13537-713-01, 13537-713-02, view more
13537-714-01, 13537-714-02, 13537-715-01, 13537-715-02, 13537-716-01, 13537-716-02, 13537-717-01, 13537-717-02, 13537-718-01, 13537-718-02, 13537-719-01, 13537-719-02, 13537-720-01, 13537-720-02
Packager: Ventura Corporation LTD

Category: HUMAN OTC DRUG LABEL

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 21, 2016

If you are a healthcare professional or from the pharmaceutical industry 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 6.8 %
Purpose

Sunscreen
Uses
- Helps prevent sunburn.
Warnings
- Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
- For external use only.
- Do not use on damaged or broken skin.
- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs.
- Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- Children under 6 months of age: Ask a doctor
Other information
- Protect the product in this container from excessive heat and direct sun.
Inactive ingredients

DIISOPROPYL DIMER DILINOLEATE, DICAPRYLYL CARBONATE, POLYETHYLENE, OCTYLDODECANOL, SILICA, CAPRYLIC/CAPRIC TRIGLYCERIDE, ZEA MAYS (CORN) STARCH, NYLON-12, TRIDECYL TRIMELLITATE, CASTOR ISOSTEARATE BEESWAX SUCCINATE, POLYGLYCERYL-3 DIISOSTEARATE, COPERNICIA CERIFERA (CARNAUBA) WAX, ISOPROPYL LANOLATE, MICROCRYSTALLINE WAX, MICA, DIISOSTEARYL MALATE, C11-12 ISOPARAFFIN, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHENOXYETHANOL, BETA-SITOSTEROL, PHENYL TRIMETHICONE, FRAGRANCE, SILICA SILYLATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, OLEYL ALCOHOL, CHLORPHENESIN, CERAMIDE 3, DIMETHICONE, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, TRIMETHYLSILOXYSILICATE, DIOLEYL TOCOPHERYL METHYLSILANOL, ALPHA-ISOMETHYL IONONE, d-LIMONENE, LINALOOL, AMYL CINNAMAL, CITRONELLOL. MAY CONTAIN: IRON OXIDES, TITANIUM DIOXIDE, RED 27 LAKE, RED 30 LAKE, YELLOW 5 LAKE, RED 7 LAKE, RED 21 LAKE, MICA, BLUE 1 LAKE, TALC.
SPL UNCLASSIFIED SECTION

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA GALA MATE - PURPLE

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRAMBUESA GLAM MATE - RED

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA DESEO MATE - PINK

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA PINK MATE - PURPLE

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

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

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - PIMIENTA CALIENTE MATE - BROWN

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FRESA PROFUNDO MATE - RED

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - FUCSIA VIBRANTE MATE - PURPLE

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)
PRINCIPAL DISPLAY PANEL - 4 g Tube Box - ROSA VIVA MATE - PINK

HD COLOR MATTE
High Definition Color
Lipstick SPF 20

ésika
PRO

Net Weight 0.14 oz. e (4 g)

INGREDIENTS AND APPEARANCE

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA GALA MATE - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-712
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-712-02	1 in 1 BOX	12/14/2015
1	NDC:13537-712-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRAMBUESA GLAM MATE - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-713
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-713-02	1 in 1 BOX	12/14/2015
1	NDC:13537-713-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA DESEO MATE - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-714
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-714-02	1 in 1 BOX	12/14/2015
1	NDC:13537-714-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA PINK MATE - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-715
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-715-02	1 in 1 BOX	12/14/2015
1	NDC:13537-715-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROJO PASION MATE - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-716
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-716-02	1 in 1 BOX	12/14/2015
1	NDC:13537-716-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 PIMIENTA CALIENTE MATE - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-717
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-717-02	1 in 1 BOX	12/14/2015
1	NDC:13537-717-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FRESA PROFUNDO MATE - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-718
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-718-02	1 in 1 BOX	12/14/2015
1	NDC:13537-718-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 FUCSIA VIBRANTE MATE - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-719
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-719-02	1 in 1 BOX	12/14/2015
1	NDC:13537-719-01	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	12/14/2015

ESIKA PRO HD COLOR MATTE HIGH DEFINITION COLOR SPF 20 ROSA VIVA MATE - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-720
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.068 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
OCTYLDODECANOL (UNII: 461N1O614Y)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STARCH, CORN (UNII: O8232NY3SJ)
NYLON-12 (UNII: 446U8J075B)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
C11-12 ISOPARAFFIN (UNII: OIY0J17X7Z)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.BETA.-SITOSTEROL (UNII: S347WMO6M4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CHLORPHENESIN (UNII: I670DAL4SZ)
CERAMIDE NP (UNII: 4370DF050B)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
D&C RED NO. 21 (UNII: 08744Z6JNY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TALC (UNII: 7SEV7J4R1U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:13537-720-02	1 in 1 BOX	12/14/2015
1	NDC:13537-720-01	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	12/14/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-712, 13537-713, 13537-714, 13537-715, 13537-716, 13537-717, 13537-718, 13537-719, 13537-720)

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Published Date (What is this?)	Version	Files
Apr 25, 2016	2 (current)	download
Dec 17, 2015	1	download

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	NDC
1	13537-712-01
2	13537-712-02 (inactivated)
3	13537-713-01
4	13537-713-02 (inactivated)
5	13537-714-01
6	13537-714-02 (inactivated)
7	13537-715-01
8	13537-715-02 (inactivated)
9	13537-716-01
10	13537-716-02 (inactivated)
11	13537-717-01
12	13537-717-02 (inactivated)
13	13537-718-01
14	13537-718-02 (inactivated)
15	13537-719-01
16	13537-719-02 (inactivated)
17	13537-720-01
18	13537-720-02 (inactivated)

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