Label: ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE- octinoxate, oxybenzone, and titanium dioxide cream
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLA .......EIGE- octinoxate, oxybenzone, and titanium dioxide cream
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE- octinoxate, oxybenzone, and titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-187-23, 13537-187-24, 13537-188-21, 13537-188-22, view more13537-189-19, 13537-189-20, 13537-190-17, 13537-190-18, 13537-191-15, 13537-191-16, 13537-192-13, 13537-192-14, 13537-193-11, 13537-193-12, 13537-194-09, 13537-194-10, 13537-195-07, 13537-195-08, 13537-196-05, 13537-196-06, 13537-197-03, 13537-197-04, 13537-198-01, 13537-198-02 - Packager: Ventura Corporation LTD
- 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 March 6, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
-
Inactive Ingredients
ISOSTEARYL NEOPENTANOATE, C12-15 ALKYL BENZOATE,POLYMETHYL METHACRYLATE, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), SILICA, MICA, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL PALMITATE, OZOKERITE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA) WAX), BENZOPHENONE-3, TITANIUM DIOXIDE, PHENOXYETHANOL, OCTYLDODECANOL, TRIMETHYLSILOXYSILICATE, DIMETHICONE, METHYLPARABEN, TOCOPHERYL ACETATE, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), PROPYLPARABEN, PETROLATUM, PHOSPHOLIPIDS, BHT, C9-13 FLUOROALCOHOL, BUTYLPARABEN, ETHYLPARABEN, PHOSPHORIC ACID, CHOLESTEROL, ISOBUTYLPARABEN, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), CERA ALBA (BEESWAX), CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, GLYCOSPHINGOLIPIDS. May contain: CI 77491 (IRON OXIDES), CI 77492 (IRON OXIDES), CI 77499 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CHITOSAN.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 1) - ROSE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 2) - ROSE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 3) - ROSE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 4) - ROSE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (ROSE 5) - ROSE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box (ROSE 6) - ROSE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 1) - BEIGE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 2) - BEIGE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 3) - BEIGE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 4) - BEIGE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 5) - BEIGE
- PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - (BEIGE 6) - BEIGE
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INGREDIENTS AND APPEARANCE
ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 1) - ROSE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-198 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-198-02 1 in 1 BOX 1 NDC:13537-198-01 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 2) - ROSE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-197 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-197-04 1 in 1 BOX 1 NDC:13537-197-03 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 3) - ROSE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-196 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-196-06 1 in 1 BOX 1 NDC:13537-196-05 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 4) - ROSE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-195 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-195-08 1 in 1 BOX 1 NDC:13537-195-07 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 5) - ROSE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-194 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-194-10 1 in 1 BOX 1 NDC:13537-194-09 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (ROSE 6) - ROSE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-193 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-193-12 1 in 1 BOX 1 NDC:13537-193-11 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 1) - BEIGE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-192-14 1 in 1 BOX 1 NDC:13537-192-13 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 2) - BEIGE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-191 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-191-16 1 in 1 BOX 1 NDC:13537-191-15 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 3) - BEIGE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-190 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-190-18 1 in 1 BOX 1 NDC:13537-190-17 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 4) - BEIGE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-189 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-189-20 1 in 1 BOX 1 NDC:13537-189-19 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 5) - BEIGE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-188 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-188-22 1 in 1 BOX 1 NDC:13537-188-21 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 ESIKA 3-IN-1 PRO MAKE UP FOUNDATION SPF 20 BASE DE MAQUILLAJE PARA ROSTRO 3-EN-1 PRO FPS 20 (BEIGE 6) - BEIGE
octinoxate, oxybenzone, and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-187 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.07 g in 1 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g in 1 g Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 0.02 g in 1 g Inactive Ingredients Ingredient Name Strength ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MICA (UNII: V8A1AW0880) ETHYLHEXYL PALMITATE (UNII: 2865993309) CARNAUBA WAX (UNII: R12CBM0EIZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) OCTYLDODECANOL (UNII: 461N1O614Y) DIMETHICONE (UNII: 92RU3N3Y1O) METHYLPARABEN (UNII: A2I8C7HI9T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PHOSPHORIC ACID (UNII: E4GA8884NN) CHOLESTEROL (UNII: 97C5T2UQ7J) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) CANDELILLA WAX (UNII: WL0328HX19) YELLOW WAX (UNII: 2ZA36H0S2V) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-187-24 1 in 1 BOX 1 NDC:13537-187-23 6 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 03/06/2014 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-198, 13537-197, 13537-196, 13537-195, 13537-194, 13537-193, 13537-192, 13537-191, 13537-190, 13537-189, 13537-188, 13537-187)