DailyMed - ESIKA- octinoxate and oxybenzone lipstick

Contains inactivated NDC Code(s)
NDC Code(s): 13537-049-01, 13537-049-02, 13537-050-01, 13537-050-02, view more
13537-051-01, 13537-051-02, 13537-052-01, 13537-052-02, 13537-053-01, 13537-053-02, 13537-054-01, 13537-054-02, 13537-055-01, 13537-055-02, 13537-056-01, 13537-056-02, 13537-057-01, 13537-057-02, 13537-058-01, 13537-058-02, 13537-059-01, 13537-059-02, 13537-060-01, 13537-060-02
Packager: Ventura Corporation (San Juan, P.R)

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 20, 2011

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

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Official Label (Printer Friendly)

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Active Ingredients

Octinoxate 6.5%, Oxybenzone 1.82%
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

Ricinus communis seed oil (ricinus communis (castor) seed oil), ethylhexyl palmitate, caprylic/capric triglyceride, polyethylene, candelilla cera (euphorbia cerifera (candelilla) wax), butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica dimethyl silylate, glycerin, octyldodecanol, parfum (fragrance), glyceryl isostearate, isostearyl alcohol, sodium saccharin, propylparaben, cera microcristallina (microcrystalline wax), beta-sitosterol, petrolatum, bht, phospholipids, cholesterol, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba ) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, CI 77742 (manganese violet), CI 77491 (iron oxides), CI 77499 (iron oxides), CI 77492 (iron oxides), CI 77891 (titanium dioxide ), CI 45410 (red 27 lake), CI 15850 (red 7 lake), CI 45380 (red 21 lake), CI 19140 (yellow 5 lake), CI 77019 (mica), CI 73360 (red 30 lake), talc, CI 42090 (blue 1 lake), CI 75470 (carmine)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO PROVOCACION

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROJO VIVAZ

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - FUCSIA FANTASIA

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - FUCSIA SEDUCTOR

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSA INTRIGA

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MORADO OBSESION

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSA COQUETA

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MALVA ILUSION

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - VINO SENSUAL

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRON OTONO

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - MARRON TENTACION

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)
PRINCIPAL DISPLAY PANEL - 4 g Carton - ROSADO MAGICO

ēsika

Ultra-Softening
Lipstick SPF 15

4 g e (.14 oz.)

INGREDIENTS AND APPEARANCE

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-049
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	RED (ROJO PROVOCACION)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-049-02	1 in 1 BOX
1	NDC:13537-049-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	RED (ROJO VIVAZ)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-050-02	1 in 1 BOX
1	NDC:13537-050-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-051
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	PURPLE (FUCSIA FANTASIA)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-051-02	1 in 1 BOX
1	NDC:13537-051-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-052
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	PURPLE (FUCSIA SEDUCTOR)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-052-02	1 in 1 BOX
1	NDC:13537-052-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-053
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	RED (ROSA INTRIGA)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-053-02	1 in 1 BOX
1	NDC:13537-053-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-054
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	BROWN (MORADO OBSESION)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-054-02	1 in 1 BOX
1	NDC:13537-054-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-055
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	RED (ROSA COQUETA)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-055-02	1 in 1 BOX
1	NDC:13537-055-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-056
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	PINK (MALVA ILUSION)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-056-02	1 in 1 BOX
1	NDC:13537-056-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-057
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	RED (VINO SENSUAL)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-057-02	1 in 1 BOX
1	NDC:13537-057-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-058
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	BROWN (MARRON OTONO)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-058-02	1 in 1 BOX
1	NDC:13537-058-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-059
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	BROWN (MARRON TENTACION)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-059-02	1 in 1 BOX
1	NDC:13537-059-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

ESIKA ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-060
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.065 g in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.0182 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
castor oil (UNII: D5340Y2I9G)
ethylhexyl palmitate (UNII: 2865993309)
medium-chain triglycerides (UNII: C9H2L21V7U)
high density polyethylene (UNII: UG00KM4WR7)
candelilla wax (UNII: WL0328HX19)
shea butter (UNII: K49155WL9Y)
yellow wax (UNII: 2ZA36H0S2V)
glycerin (UNII: PDC6A3C0OX)
octyldodecanol (UNII: 461N1O614Y)
glyceryl isostearate (UNII: HYE7O27HAO)
isostearyl alcohol (UNII: Q613OCQ44Y)
saccharin sodium (UNII: SB8ZUX40TY)
propylparaben (UNII: Z8IX2SC1OH)
microcrystalline wax (UNII: XOF597Q3KY)
.beta.-sitosterol (UNII: S347WMO6M4)
petrolatum (UNII: 4T6H12BN9U)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
cholesterol (UNII: 97C5T2UQ7J)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetearyl glucoside (UNII: 09FUA47KNA)
carnauba wax (UNII: R12CBM0EIZ)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
ferric oxide yellow (UNII: EX438O2MRT)
titanium dioxide (UNII: 15FIX9V2JP)
D&C red no. 27 (UNII: 2LRS185U6K)
D&C red no. 7 (UNII: ECW0LZ41X8)
D&C red no. 21 (UNII: 08744Z6JNY)
FD&C yellow no. 5 (UNII: I753WB2F1M)
D&C red no. 30 (UNII: 2S42T2808B)
FD&C blue no. 1 (UNII: H3R47K3TBD)
aluminum oxide (UNII: LMI26O6933)
mica (UNII: V8A1AW0880)
talc (UNII: 7SEV7J4R1U)
cochineal (UNII: TZ8Z31B35M)

Product Characteristics
Color	PINK (ROSADO MAGICO)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:13537-060-02	1 in 1 BOX
1	NDC:13537-060-01	4 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	09/23/2011

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

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

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Label: ESIKA- octinoxate and oxybenzone lipstick

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	NDC
1	13537-049-01
2	13537-049-02 (inactivated)
3	13537-050-01
4	13537-050-02 (inactivated)
5	13537-051-01
6	13537-051-02 (inactivated)
7	13537-052-01
8	13537-052-02 (inactivated)
9	13537-053-01
10	13537-053-02 (inactivated)
11	13537-054-01
12	13537-054-02 (inactivated)
13	13537-055-01
14	13537-055-02 (inactivated)
15	13537-056-01
16	13537-056-02 (inactivated)
17	13537-057-01
18	13537-057-02 (inactivated)
19	13537-058-01
20	13537-058-02 (inactivated)
21	13537-059-01
22	13537-059-02 (inactivated)
23	13537-060-01
24	13537-060-02 (inactivated)

Label: ESIKA- octinoxate and oxybenzone lipstick

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Drug Label Information

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ESIKA- octinoxate and oxybenzone lipstick

Number of versions: 1

ESIKA- octinoxate and oxybenzone lipstick

ESIKA- octinoxate and oxybenzone lipstick

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ESIKA- octinoxate and oxybenzone lipstick

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