ESIKA  CORE SENSATIONS- octinoxate and oxybenzone lipstick 
Ventura Corporation (San Juan, P.R)

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.

----------

ēsika
Core Sensations
Lipstick

Active Ingredients

Octinoxate 6.5%, Oxybenzone 2%

Uses

Helps prevent sunburn.

Warnings

For external use only.

Stop use if skin rash occurs.

Keep out of reach of children.

Directions

Apply evenly before sun exposure and as needed. Apply lipstick following the curves of natural lip line.

Inactive Ingredients

Caprylic/capric triglyceride, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, octyldodecanol, vp/hexadecene copolymer, candelilla cera (euphorbia cerifera (candelilla) wax), castor isostearate beeswax succinate, cera alba (beeswax), ozokerite, polyethylene, copernicia cerifera cera (copernicia cerifera (carnauba) wax), tridecyl stearate, silica, glyceryl isostearate, isostearyl alcohol, myristyl myristate, neopentyl glycol dicaprylate/dicaprate, parfum (fragrance), butyrospermum parkii butter (butyrospermum parkii (shea) butter), glycerin, isopropyl myristate, mentha piperita oil (mentha piperita (peppermint) oil), beta-sitosterol, brassica campestris seed oil (brassica campestris (rapeseed) seed oil), sodium saccharin, phenoxyethanol, disteardimonium hectorite, silica silylate, ethyl menthane carboxamide, menthoxypropanediol, microcristallina cera (microcrystalline wax), tocopheryl acetate, methylparaben, petrolatum, phospholipids, bht, mica, schinus terebinthifolius seed extract, propylparaben, cholesterol, butylparaben, ethylparaben, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, glycosphingolipids, dimethicone, trimethylsiloxysilicate. May Contain: diisopropyl dimer dilinoleate, ricinus communis seed oil (ricinus communis (castor) seed oil), hydrogenated polyisobutene, cetyl alcohol, menthyl lactate, propylene glycol, dipalmitoyl hydroxyproline, CI 15850 (red 7 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides), CI 77019 (mica), CI 45410 (red 27 lake), CI 77891 (titanium dioxide ), CI 19140 (yellow 5 lake), CI 45380 (red 21 lake), CI 75470 (carmine), ppg-26-buteth-26, bertholletia excelsa seed oil, orbignya oleifera seed oil, peg-40 hydrogenated castor oil, silica dimethyl silylate, cetearyl ethylhexanoate, aqua (water), hydrogenated coconut oil, oleyl alcohol, cetyl ricinoleate, talc.

PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRÓN DELICIA

ēsika
Core Sensations
Lipstick

4 g e (.14 oz.)

Principal Display Panel
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-364
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBROWN (MARRÓN DELICIA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-364-021 in 1 CARTON
1NDC:13537-364-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-365
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED (ROJO AMOROSO) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-365-021 in 1 CARTON
1NDC:13537-365-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-366
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorORANGE (CIRUELA CONFIDENTE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-366-021 in 1 CARTON
1NDC:13537-366-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-367
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED (FRESA COQUETA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-367-021 in 1 CARTON
1NDC:13537-367-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-368
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED, PINK (MAGENTA ENAMORADA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-368-021 in 1 CARTON
1NDC:13537-368-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-369
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED (ROSA TERNURA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-369-021 in 1 CARTON
1NDC:13537-369-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED, PINK (MALVA ROMÁNTICA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-370-021 in 1 CARTON
1NDC:13537-370-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-371
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED (VINO SEDUCTOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-371-021 in 1 CARTON
1NDC:13537-371-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-372
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorBROWN (BRONCE CAUTIVANTE) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-372-021 in 1 CARTON
1NDC:13537-372-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-373
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorRED (FUCSIA FESTIVA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-373-021 in 1 CARTON
1NDC:13537-373-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
ESIKA   CORE SENSATIONS
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-374
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.020 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
CASTOR OIL (UNII: D5340Y2I9G)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CANDELILLA WAX (UNII: WL0328HX19)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MENTHYL LACTATE (UNII: 2BF9E65L7I)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DICAPRATE (UNII: 77T908SE82)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BRASSICA RAPA VAR. RAPA OIL (UNII: N4G8379626)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PETROLATUM (UNII: 4T6H12BN9U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MICA (UNII: V8A1AW0880)  
BRAZILIAN PEPPER (UNII: SUG822G7CD)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
BRAZIL NUT OIL (UNII: 0G89T29HO6)  
BABASSU OIL (UNII: 8QSB4M5477)  
POLYETHYLENE GLYCOL 2000 (UNII: HAF0412YIT)  
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
WATER (UNII: 059QF0KO0R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLEYL ALCOHOL (UNII: 172F2WN8DV)  
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorORANGE (CORAL ENCANTADOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-374-021 in 1 CARTON
1NDC:13537-374-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35206/02/2011
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Yobel Supply Chain Management, S. A.934116930MANUFACTURE

Revised: 7/2011
Document Id: e2b92c3a-a65d-4c5a-895b-dd8c9ff0235d
Set id: 20a0267e-6647-4e7b-aec4-a8ae59bf7c98
Version: 2
Effective Time: 20110721
 
Ventura Corporation (San Juan, P.R)