ESIKA- octinoxate and oxybenzone lipstick

ESIKA by

Drug Labeling and Warnings

ESIKA by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation (San Juan, P.R), Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.3%, Oxybenzone 1.65%

Use

Helps prevent sunburn.

Warnings

For external use only.

Stop use if skin rash occurs.

Keep out of reach of children.

Directions

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

Inactive Ingredients

Diisopropyl dimer dilinoleate, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyethylene, butyrospermum parkii butter (butyrospermum parkii (shea) butter), silica, octyldodecanol, aqua (water), phenoxyethanol, microcristallina cera (microcrystalline wax), petrolatum, phospholipids, methylparaben, parfum (fragrance), bht, cholesterol, butylparaben, ethylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, isobutylparaben, propylparaben, glycosphingolipids, maltodextrin, zea mays starch( zea mays (corn) starch), sodium hyaluronate, CI 15850 (red 7 lake), CI 45410 (red 27 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), CI 77499 (iron oxides), CI 77019 (mica), CI 19140 (yellow 5 lake), CI 77891 (titanium dioxide ), CI 15850 (red 6 lake), isononyl isononanoate, talc, isopropyl myristate, CI 42090 (blue 1 lake), CI 75470 (carmine), isopropyl titanium triisostearate, triethoxycaprylylsilane, stearalkonium hectorite, C9-15 fluoroalcohol phosphate, polyhydroxystearic acid, propylene carbonate.

PRINCIPAL DISPLAY PANEL - 4 g Carton - Rojo Amor

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Naranja Vivaz

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Rojo Cherry

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Fucsia Fancy

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Magenta Atrevida

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Vino Glamour

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Rosa Divina

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Coral Shine

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Mocca Misterio

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

PRINCIPAL DISPLAY PANEL - 4 g Carton - Marron Calido

ēsika

Maximum Color
Lipstick SPF 18

4 g e (.14 oz.)

INGREDIENTS AND APPEARANCE

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-343
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	RED (Rojo Amor)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-343-02	1 in 1 BOX
1	NDC: 13537-343-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-344
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	ORANGE (Naranja Vivaz)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-344-02	1 in 1 BOX
1	NDC: 13537-344-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-345
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	RED (Rojo Cherry)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-345-02	1 in 1 BOX
1	NDC: 13537-345-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-346
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	PINK (Fucsia Fancy)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-346-02	1 in 1 BOX
1	NDC: 13537-346-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-347
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	PURPLE (Magenta Atrevida)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-347-02	1 in 1 BOX
1	NDC: 13537-347-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-348
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	RED (Vino Glamour)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-348-02	1 in 1 BOX
1	NDC: 13537-348-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-349
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	RED (Rosa Divina)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-349-02	1 in 1 BOX
1	NDC: 13537-349-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	RED (Coral Shine)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-350-02	1 in 1 BOX
1	NDC: 13537-350-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-351
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	BROWN (Mocca Misterio)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-351-02	1 in 1 BOX
1	NDC: 13537-351-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

ESIKA   MAXIMUM COLOR SPF 18
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-352
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.073 g  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0165 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ethylhexyl palmitate (UNII: 2865993309)
carnauba wax (UNII: R12CBM0EIZ)
shea butter (UNII: K49155WL9Y)
silicon dioxide (UNII: ETJ7Z6XBU4)
octyldodecanol (UNII: 461N1O614Y)
water (UNII: 059QF0KO0R)
phenoxyethanol (UNII: HIE492ZZ3T)
microcrystalline wax (UNII: XOF597Q3KY)
petrolatum (UNII: 4T6H12BN9U)
methylparaben (UNII: A2I8C7HI9T)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
butylparaben (UNII: 3QPI1U3FV8)
ethylparaben (UNII: 14255EXE39)
candelilla wax (UNII: WL0328HX19)
yellow wax (UNII: 2ZA36H0S2V)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
isobutylparaben (UNII: 0QQJ25X58G)
propylparaben (UNII: Z8IX2SC1OH)
maltodextrin (UNII: 7CVR7L4A2D)
starch, corn (UNII: O8232NY3SJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
d&c red no. 7 (UNII: ECW0LZ41X8)
d&c red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)
fd&c yellow no. 5 (UNII: I753WB2F1M)
titanium dioxide (UNII: 15FIX9V2JP)
d&c red no. 6 (UNII: 481744AI4O)
isononyl isononanoate (UNII: S4V5BS6GCX)
talc (UNII: 7SEV7J4R1U)
isopropyl myristate (UNII: 0RE8K4LNJS)
fd&c blue no. 1 (UNII: H3R47K3TBD)
cochineal (UNII: TZ8Z31B35M)
triethoxycaprylylsilane (UNII: LDC331P08E)
propylene carbonate (UNII: 8D08K3S51E)

Product Characteristics
Color	BROWN (Marron Calido)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-352-02	1 in 1 BOX
1	NDC: 13537-352-01	4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/17/2011

Labeler - Ventura Corporation (San Juan, P.R) (602751344)

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