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 (octinoxat ....... 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

ESIKA Extreme Moisturizing SPF 16 by

Drug Labeling and Warnings

ESIKA Extreme Moisturizing SPF 16 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Octinoxate 6.6%	Sunscreen
Oxybenzone 1.5 %	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

• For external use only.

• Do not use on damaged or broken skin.

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Children under 6 months of age: Ask a doctor

Other information

• Protect the product in this container from excessive heat and direct sun.
• Apply lipstick following the curves of natural lip line. For added definition, use with a lip penCIl.

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.

SPL UNCLASSIFIED SECTION

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 - Café Moca - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Fucsia Cautivante - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Granate Seductor - Purple

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Marron Glamour - Brown

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Naranja Primavera - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 Intrigante - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Rosa Diva - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 Esplendor - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Cereza Hechizo - Red

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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 - Rosa Dulzura - Pink

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

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

ēsika

Extreme
Moisturizing Lipstick
SPF 16

Net Weight 0.14 oz. (4 g)

INGREDIENTS AND APPEARANCE

ESIKA EXTREME MOISTURIZING SPF 16   (BORGONA SEXY) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-277
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-277-02	1 in 1 BOX
1	NDC: 13537-277-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (CAFE MOCA) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-278
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-278-04	1 in 1 BOX
1	NDC: 13537-278-03	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (CORAL CHIC) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-379
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-379-06	1 in 1 BOX
1	NDC: 13537-379-05	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (FUCSIA CAUTIVANTE) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-280
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-280-08	1 in 1 BOX
1	NDC: 13537-280-07	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (FUCSIA GLAM) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-281
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-281-10	1 in 1 BOX
1	NDC: 13537-281-09	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (GRANATE SEDUCTOR) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-282
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-282-12	1 in 1 BOX
1	NDC: 13537-282-11	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (MAGENTA TRAVIESA) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-283-14	1 in 1 BOX
1	NDC: 13537-283-13	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (MARRON GLAMOUR) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-284
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-284-16	1 in 1 BOX
1	NDC: 13537-284-15	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (MORADO EXUBERANTE) - PURPLE
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-285
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-285-18	1 in 1 BOX
1	NDC: 13537-285-17	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (NARANJA PRIMAVERA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-286
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-286-20	1 in 1 BOX
1	NDC: 13537-286-19	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROJO DESEO) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-287
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-287-22	1 in 1 BOX
1	NDC: 13537-287-21	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROJO INTRIGANTE) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-288
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-288-24	1 in 1 BOX
1	NDC: 13537-288-23	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROJO LUJURIA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-289-26	1 in 1 BOX
1	NDC: 13537-289-25	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROSA DIVA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-290
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-290-28	1 in 1 BOX
1	NDC: 13537-290-27	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROSA ENCANTO) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-291-30	1 in 1 BOX
1	NDC: 13537-291-29	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROSA ESPLENDOR) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-292
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-292-32	1 in 1 BOX
1	NDC: 13537-292-31	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROSA ROMANTICA) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-293
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-293-34	1 in 1 BOX
1	NDC: 13537-293-33	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (CEREZA HECHIZO) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-294
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-294-36	1 in 1 BOX
1	NDC: 13537-294-35	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (FRAMBUESA MANIA) - RED
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-295
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-295-38	1 in 1 BOX
1	NDC: 13537-295-37	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (ROSA DULZURA) - PINK
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-296
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-296-40	1 in 1 BOX
1	NDC: 13537-296-39	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

ESIKA EXTREME MOISTURIZING SPF 16   (PIMIENTA CALIENTE) - BROWN
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-297
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.066 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.015 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-297-42	1 in 1 BOX
1	NDC: 13537-297-41	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	12/16/2013

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(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)