ESIKA ULTRA SOFTENING SPF 15- octinoxate and oxybenzone lipstick 
Ventura Corporation (San Juan, P.R)

----------

Esika Ultra-Softening Lipstick FPS 15

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)

Purpose

Sunscreen

Keep out of reach of children.

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ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorred (ROJO PROVOCACION) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-049-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-049-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorred (ROJO VIVAZ) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-050-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-050-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorpurple (FUCSIA FANTASIA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-051-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-051-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorpurple (FUCSIA SEDUCTOR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-052-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-052-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-053
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorred (ROSA INTRIGA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-053-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-053-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (MORADO OBSESION) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-054-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-054-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorred (ROSA COQUETA) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-055-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-055-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (MALVA ILUSION) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-056-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-056-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorred (VINO SENSUAL) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-057-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-057-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (MARRON OTONO) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-058-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-058-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-059
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorbrown (MARRON TENTACION) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-059-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-059-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
ESIKA  ULTRA SOFTENING SPF 15
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.0182 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (ROSADO MAGICO) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-060-021 in 1 BOX09/23/201112/31/2021
1NDC:13537-060-014 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02009/23/201112/31/2021
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-049, 13537-050, 13537-051, 13537-052, 13537-053, 13537-054, 13537-055, 13537-056, 13537-057, 13537-058, 13537-059, 13537-060)

Revised: 3/2025
 
Ventura Corporation (San Juan, P.R)