DailyMed - ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FRESA TENTACION) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CAFE MISTERIO) - BROWN- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROSA DESEO) - BROWN- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (BURGUNDY VITAL) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (VINO SUBLIME) - RED- octinoxate lipstick ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROJO RADIANT)

Contains inactivated NDC Code(s)
NDC Code(s): 14783-113-01, 14783-113-02, 14783-114-01, 14783-114-02, view more
14783-115-01, 14783-115-02, 14783-116-01, 14783-116-02, 14783-117-01, 14783-117-02, 14783-118-01, 14783-118-02, 14783-822-01, 14783-822-02, 14783-823-01, 14783-823-02, 14783-824-01, 14783-824-02, 14783-825-01, 14783-825-02, 14783-826-01, 14783-826-02, 14783-827-01, 14783-827-02, 14783-828-01, 14783-828-02, 14783-829-01, 14783-829-02, 14783-830-01, 14783-830-02, 14783-831-01, 14783-831-02, 14783-832-01, 14783-832-02
Packager: Ventura International 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 September 6, 2017

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

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

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SPL UNCLASSIFIED SECTION

Drug Facts
Active Ingredients

Octinoxate 7.50 %
Purpose

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

LIPSTICK

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

MAY CONTAIN :

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

LIP LINER

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

MAY CONTAIN :

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

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL 33126.
PRINCIPAL DISPLAY PANEL - 2,2 g Tube Box - (FRESA TENTACIÓN) - RED

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

ésika
PRO

PERFECT MATCH VOLUMEN

Lipstick SPF 20 + Lip liner for maximum fullness

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

INGREDIENTS AND APPEARANCE

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FRESA TENTACION) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-822
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-822-02	1 in 1 BOX	08/28/2015
1	NDC:14783-822-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CAFE MISTERIO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-823
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-823-02	1 in 1 BOX	08/28/2015
1	NDC:14783-823-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROSA DESEO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-824
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-824-02	1 in 1 BOX	08/28/2015
1	NDC:14783-824-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (DURAZNO AMOR) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-825
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-825-02	1 in 1 BOX	08/28/2015
1	NDC:14783-825-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS -(ROSA GOLOSA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-826
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-826-02	1 in 1 BOX	08/28/2015
1	NDC:14783-826-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CORAL SEDUCTOR) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-827
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-827-02	1 in 1 BOX	08/28/2015
1	NDC:14783-827-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CEREZA SEXY) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-828
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-828-02	1 in 1 BOX	08/28/2015
1	NDC:14783-828-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FUCSIA SENSUAL) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-829
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-829-02	1 in 1 BOX	08/28/2015
1	NDC:14783-829-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROJO PASION) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-830
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-830-02	1 in 1 BOX	08/28/2015
1	NDC:14783-830-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (VINO CALIENTE) - PURPLE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-831
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-831-02	1 in 1 BOX	08/28/2015
1	NDC:14783-831-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (PIMIENTA CALIENTE) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-832
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-832-02	1 in 1 BOX	08/28/2015
1	NDC:14783-832-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (CAFE PARISO) - BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-113
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-113-02	1 in 1 BOX	08/28/2015
1	NDC:14783-113-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROSE BLOOM) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-114
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-114-02	1 in 1 BOX	08/28/2015
1	NDC:14783-114-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (FRESA ENERGY) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-115
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-115-02	1 in 1 BOX	08/28/2015
1	NDC:14783-115-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (BURGUNDY VITAL) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-116
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-116-02	1 in 1 BOX	08/28/2015
1	NDC:14783-116-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (VINO SUBLIME) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-117
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-117-02	1 in 1 BOX	08/28/2015
1	NDC:14783-117-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

ESIKA PRO PERFECT MATCH VOLUMEN SPF 20 PLUS LIP LINER FOR MAXIMUM FULLNESS - (ROJO RADIANT) - RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14783-118
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
tridecyl trimellitate (UNII: FY36J270ES)
medium-chain triglycerides (UNII: C9H2L21V7U)
tridecyl stearate (UNII: A8OE252M6L)
high density polyethylene (UNII: UG00KM4WR7)
carnauba wax (UNII: R12CBM0EIZ)
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)
shea butter (UNII: K49155WL9Y)
silica dimethyl silylate (UNII: EU2PSP0G0W)
phenoxyethanol (UNII: HIE492ZZ3T)
cetearyl ethylhexanoate (UNII: 9M64UO4C25)
glycerin (UNII: PDC6A3C0OX)
caprylyl glycol (UNII: 00YIU5438U)
chlorphenesin (UNII: I670DAL4SZ)
ceramide np (UNII: 4370DF050B)
saccharin sodium (UNII: SB8ZUX40TY)
sorbitan isostearate (UNII: 01S2G2C1E4)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sucrose cocoate (UNII: 3H18P0UK73)
palmitoyl lysyldioxymethionyllysine (UNII: T7A529FB8O)
ferric oxide red (UNII: 1K09F3G675)
manganese violet (UNII: 72M48QQV8Q)
mica (UNII: V8A1AW0880)
d&c red no. 30 (UNII: 2S42T2808B)
aluminum oxide (UNII: LMI26O6933)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c yellow no. 5 (UNII: I753WB2F1M)
d&c red no. 27 (UNII: 2LRS185U6K)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 21 (UNII: 08744Z6JNY)
talc (UNII: 7SEV7J4R1U)
fd&c blue no. 1 (UNII: H3R47K3TBD)
Isododecane (UNII: A8289P68Y2)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 5 (UNII: 0THT5PCI0R)
disteardimonium hectorite (UNII: X687XDK09L)
propylene carbonate (UNII: 8D08K3S51E)
fd&c red no. 40 (UNII: WZB9127XOA)
isomethyl-.alpha.-ionone (UNII: 9XP4LC555B)
limonene, (+)- (UNII: GFD7C86Q1W)
linalool, (+/-)- (UNII: D81QY6I88E)
.alpha.-amylcinnamaldehyde (UNII: WC51CA3418)
.beta.-citronellol, (r)- (UNII: P01OUT964K)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:14783-118-02	1 in 1 BOX	08/28/2015
1	NDC:14783-118-01	2.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/28/2015

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-822, 14783-823, 14783-824, 14783-825, 14783-826, 14783-827, 14783-828, 14783-829, 14783-830, 14783-831, 14783-832, 14783-822, 14783-113, 14783-114, 14783-115, 14783-116, 14783-117, 14783-118)

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Published Date (What is this?)	Version	Files
Sep 7, 2017	2 (current)	download
Oct 1, 2015	1	download

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	NDC
1	14783-113-01
2	14783-113-02 (inactivated)
3	14783-114-01
4	14783-114-02 (inactivated)
5	14783-115-01
6	14783-115-02 (inactivated)
7	14783-116-01
8	14783-116-02 (inactivated)
9	14783-117-01
10	14783-117-02 (inactivated)
11	14783-118-01
12	14783-118-02 (inactivated)
13	14783-822-01
14	14783-822-02 (inactivated)
15	14783-823-01
16	14783-823-02 (inactivated)
17	14783-824-01
18	14783-824-02 (inactivated)
19	14783-825-01
20	14783-825-02 (inactivated)
21	14783-826-01
22	14783-826-02 (inactivated)
23	14783-827-01
24	14783-827-02 (inactivated)
25	14783-828-01
26	14783-828-02 (inactivated)
27	14783-829-01
28	14783-829-02 (inactivated)
29	14783-830-01
30	14783-830-02 (inactivated)
31	14783-831-01
32	14783-831-02 (inactivated)
33	14783-832-01
34	14783-832-02 (inactivated)

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