ESIKA  HYDRATED FACE MAKEUP FOUNDATION SPF 15- octinoxate powder 
Ventura Corporation (San Juan, P.R)

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

----------

ēsika
Hydrated Face Makeup Foundation SPF 15

Drug Facts

Active Ingredients

Octinoxate (6%)

Purpose

Sunscreen

Uses

Warnings

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash and irritation develops and lasts.

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

Directions

Other information

Inactive ingredients

Aqua (water), coco-caprylate/caprate, ethylhexyl palmitate, glycerin, octyldodecanol, polymethyl methacrylate, cyclopentasiloxane, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, sodium chloride, talc, dimethicone, hexyl laurate, dimethicone/vinyl dimethicone crosspolymer, cyclomethicone, disteardimonium hectorite, cyclohexasiloxane, glycine soja protein (glycine soja (soybean) protein), microcrystalline wax, diazolidinyl urea, cetearyl dimethicone crosspolymer, methylparaben, propylparaben, tocopheryl acetate, petrolatum, dimethiconol, phospholipids, cholesterol, silica, bha, bht, candelilla cera (euphorbia cerifera (candelilla) wax), beeswax, cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, triethoxycaprylylsilane, ci 77891 (titanium dioxide ), ci 77492 (iron oxides), ci 77491( iron oxides), ci 77499 (iron oxides).

PRINCIPAL DISPLAY PANEL - 30 g Carton

ēsika

Hydrated Face Makeup Foundation SPF 15

30 g e (1 oz.)

Principal Display Panel - 30 g Carton
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-317
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige 1) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-317-021 in 1 BOX
1NDC:13537-317-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-318
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige 2) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-318-021 in 1 BOX
1NDC:13537-318-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige 3) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-319-021 in 1 BOX
1NDC:13537-319-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-320
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige 4) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-320-021 in 1 BOX
1NDC:13537-320-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige 5) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-321-021 in 1 BOX
1NDC:13537-321-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-322
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige 6) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-322-021 in 1 BOX
1NDC:13537-322-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-323
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rosa 1) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-323-021 in 1 BOX
1NDC:13537-323-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-324
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rosa 2) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-324-021 in 1 BOX
1NDC:13537-324-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-325
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rosa 3) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-325-021 in 1 BOX
1NDC:13537-325-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rosa 4) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-326-021 in 1 BOX
1NDC:13537-326-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rosa 5) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-327-021 in 1 BOX
1NDC:13537-327-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
ESIKA   HYDRATED FACE MAKEUP FOUNDATION SPF 15
octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-328
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
GLYCERIN (UNII: PDC6A3C0OX)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TALC (UNII: 7SEV7J4R1U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
SOYBEAN (UNII: L7HT8F1ZOD)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PETROLATUM (UNII: 4T6H12BN9U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CANDELILLA WAX (UNII: WL0328HX19)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rosa 6) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-328-021 in 1 BOX
1NDC:13537-328-0130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35205/17/2011
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 5/2011
Document Id: d6c64fef-cbe6-4ccd-92d4-803463c61be2
Set id: 1e358ffd-cf08-4b66-b3b5-12daa362c5c5
Version: 1
Effective Time: 20110518
 
Ventura Corporation (San Juan, P.R)