ESIKA EXTREME MOISTURIZING SPF 16  (BORGONA SEXY) - BROWN- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (CAFE MOCA) - BROWN- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (CORAL CHIC) - PINK- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (FUCSIA CAUTIVANTE) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (FUCSIA GLAM) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (GRANATE SEDUCTOR) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (MAGENTA TRAVIESA) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (MARRON GLAMOUR) - BROWN- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (MORADO EXUBERANTE) - PURPLE- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (NARANJA PRIMAVERA) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROJO DESEO) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROJO INTRIGANTE) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROJO LUJURIA) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROSA DIVA) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROSA ENCANTO) - PINK- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROSA ESPLENDOR) - PINK- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROSA ROMANTICA) - PINK- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (CEREZA HECHIZO) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (FRAMBUESA MANIA) - RED- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (ROSA DULZURA) - PINK- octinoxate and oxybenzone lipstick 
ESIKA EXTREME MOISTURIZING SPF 16  (PIMIENTA CALIENTE) - BROWN- octinoxate and oxybenzone lipstick 
Ventura Corporation LTD

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 Extreme Moisturizing Lipstick SPF 16

Drug Facts

Active IngredientsPurpose
Octinoxate 6.6%Sunscreen
Oxybenzone 1.5 %Sunscreen

Uses

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

Other information

Inactive ingredients

Dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, ethylhexyl palmitate, ozokerite, polyethylene, polymethyl methacrylate,water, polyglyceryl-3 diisostearate, tridecyl stearate, copernicia cerifera (carnauba) wax, glycerin, neopentyl glycol dicaprylate/dicaprate, kaolin, octyldodecanol, phenoxyethanol, sodium starch octenylsuccinate, tocopheryl acetate, microcrystalline wax, fragrance, methylparaben, petrolatum, phospholipids, propylparaben, cholesterol, butyrospermum parkii (shea) butter, glycine soja (soybean) oil, butylparaben, ethylparaben, bht,euphorbia cerifera (candelilla) wax, beeswax, cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, tocopherol, glycosphingolipids, magnesium chloride, potassium chloride, hydrated silica, sodium chloride.

May contain: red 7 lake , mica, iron oxides, titanium dioxide, bismuth oxychloride, iron oxides, red 21 lake, yellow 5 lake, iron oxides, red 27 lake , talc, blue 1 lake, chitosan, carmine.

PR: Distributed by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Borgona Sexy - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Borgona Sexy - Brown

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Café Moca - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Café Moca - Brown

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Coral Chic - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Coral Chic - Pink

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia Cautivante - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Fucsia Cautivante - Purple

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia Glam - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Fucsia Glam - Purple

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Granate Seductor - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Granate Seductor - Purple

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Magenta Traviesa - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Magenta Traviesa - Purple

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Marron Glamour - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Marron Glamour - Brown

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Morado Exuberante - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Morado Exuberante - Purple

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Naranja Primavera - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Naranja Primavera - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rojo Deseo - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rojo Deseo - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rojo Intrigante - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rojo Intrigante - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rojo Lujuria - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rojo Lujuria - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Diva - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rosa Diva - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Encanto - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rosa Encanto - Pink

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Esplendor - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rosa Esplendor - Pink

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Romántica - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rosa Romántica - Pink

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Cereza Hechizo - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Cereza Hechizo - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Frambuesa Manía - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Frambuesa Manía - Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rosa Dulzura - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Rosa Dulzura - Pink

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Pimienta Caliente - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

Principal Display Panel - 4 g Tube Box - Pimienta Caliente - Brown
ESIKA EXTREME MOISTURIZING SPF 16   (BORGONA SEXY) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-277
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-277-021 in 1 BOX
1NDC:13537-277-014 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (CAFE MOCA) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-278
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-278-041 in 1 BOX
1NDC:13537-278-034 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-379
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-379-061 in 1 BOX
1NDC:13537-379-054 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (FUCSIA CAUTIVANTE) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-280
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-280-081 in 1 BOX
1NDC:13537-280-074 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (FUCSIA GLAM) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-281
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-281-101 in 1 BOX
1NDC:13537-281-094 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-282
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-282-121 in 1 BOX
1NDC:13537-282-114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (MAGENTA TRAVIESA) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-283
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-283-141 in 1 BOX
1NDC:13537-283-134 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-284
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-284-161 in 1 BOX
1NDC:13537-284-154 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (MORADO EXUBERANTE) - PURPLE
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-285
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-285-181 in 1 BOX
1NDC:13537-285-174 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (NARANJA PRIMAVERA) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-286
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-286-201 in 1 BOX
1NDC:13537-286-194 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROJO DESEO) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-287
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-287-221 in 1 BOX
1NDC:13537-287-214 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-288
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-288-241 in 1 BOX
1NDC:13537-288-234 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-289
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-289-261 in 1 BOX
1NDC:13537-289-254 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROSA DIVA) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-290
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-290-281 in 1 BOX
1NDC:13537-290-274 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-291
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-291-301 in 1 BOX
1NDC:13537-291-294 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROSA ESPLENDOR) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-292
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-292-321 in 1 BOX
1NDC:13537-292-314 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-293
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-293-341 in 1 BOX
1NDC:13537-293-334 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (CEREZA HECHIZO) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-294
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-294-361 in 1 BOX
1NDC:13537-294-354 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-295
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-295-381 in 1 BOX
1NDC:13537-295-374 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-296
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetearyl glucoside (UNII: 09FUA47KNA)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-296-401 in 1 BOX
1NDC:13537-296-394 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
ESIKA EXTREME MOISTURIZING SPF 16   (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-297
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)  
tridecyl trimellitate (UNII: FY36J270ES)  
ethylhexyl palmitate (UNII: 2865993309)  
high density polyethylene (UNII: UG00KM4WR7)  
water (UNII: 059QF0KO0R)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
tridecyl stearate (UNII: A8OE252M6L)  
carnauba wax (UNII: R12CBM0EIZ)  
glycerin (UNII: PDC6A3C0OX)  
neopentyl glycol dicaprylate/dicaprate (UNII: VLW429K27K)  
kaolin (UNII: 24H4NWX5CO)  
octyldodecanol (UNII: 461N1O614Y)  
phenoxyethanol (UNII: HIE492ZZ3T)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
microcrystalline wax (UNII: XOF597Q3KY)  
methylparaben (UNII: A2I8C7HI9T)  
petrolatum (UNII: 4T6H12BN9U)  
propylparaben (UNII: Z8IX2SC1OH)  
cholesterol (UNII: 97C5T2UQ7J)  
shea butter (UNII: K49155WL9Y)  
soybean oil (UNII: 241ATL177A)  
butylparaben (UNII: 3QPI1U3FV8)  
ethylparaben (UNII: 14255EXE39)  
butylated hydroxytoluene (UNII: 1P9D0Z171K)  
candelilla wax (UNII: WL0328HX19)  
yellow wax (UNII: 2ZA36H0S2V)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
cetearyl glucoside (UNII: 09FUA47KNA)  
isobutylparaben (UNII: 0QQJ25X58G)  
tocopherol (UNII: R0ZB2556P8)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
hydrated silica (UNII: Y6O7T4G8P9)  
sodium chloride (UNII: 451W47IQ8X)  
d&c red no. 7 (UNII: ECW0LZ41X8)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
bismuth oxychloride (UNII: 4ZR792I587)  
d&c red no. 21 (UNII: 08744Z6JNY)  
fd&c yellow no. 5 (UNII: I753WB2F1M)  
d&c red no. 27 (UNII: 2LRS185U6K)  
fd&c blue no. 1 (UNII: H3R47K3TBD)  
talc (UNII: 7SEV7J4R1U)  
aluminum oxide (UNII: LMI26O6933)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-297-421 in 1 BOX
1NDC:13537-297-414 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/16/2013
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-277, 13537-278, 13537-379, 13537-280, 13537-281, 13537-282, 13537-283, 13537-284, 13537-285, 13537-286, 13537-287, 13537-288, 13537-289, 13537-290, 13537-291, 13537-292, 13537-293, 13537-294, 13537-295, 13537-296, 13537-297)

Revised: 12/2013
Document Id: 9e47161d-96ba-471f-8573-edb456612cd2
Set id: 940d673e-1002-4e0e-85d6-1b974dfe0e3d
Version: 1
Effective Time: 20131220
 
Ventura Corporation LTD