Label: ESIKA- octinoxate, oxybenzone, and titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-329-01, 13537-329-02, 13537-330-01, 13537-330-02, view more13537-331-01, 13537-331-02, 13537-332-01, 13537-332-02, 13537-333-01, 13537-333-02, 13537-334-01, 13537-334-02, 13537-335-01, 13537-335-02, 13537-336-01, 13537-336-02, 13537-337-01, 13537-337-02, 13537-338-01, 13537-338-02, 13537-339-01, 13537-339-02, 13537-340-01, 13537-340-02 - 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 May 18, 2011
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Isostearyl neopentanoate, C12-15 alkyl benzoate, polymethyl methacrylate, corn starch, silica, mica, ethylhexyl palmitate, ozokerite, copernicia cerifera cera (copernicia cerifera (carnauba) wax), phenoxyethanol, octyldodecanol, trimethylsiloxysilicate, dimethicone, methylparaben, tocopheryl acetate, microcrystalline wax, propylparaben, petrolatum, phospholipids, bht, c9-13 fluoroalcohol, butylparaben, ethylparaben, phosphoric acid, cholesterol, isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, polyglyceryl-2 dipolyhydroxystearate, glycosphingolipids, chitosan, ci 77492 (iron oxides), ci 77491 (iron oxides), ci 77499 (iron oxides).
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 1
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 2
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 3
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 4
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 5
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Beige 6
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 1
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 2
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 3
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 4
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 5
- PRINCIPAL DISPLAY PANEL - 6 g Carton - Rosa 6
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INGREDIENTS AND APPEARANCE
ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-329 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (Beige 1) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-329-02 1 in 1 BOX 1 NDC:13537-329-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-330 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (Beige 2) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-330-02 1 in 1 BOX 1 NDC:13537-330-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-331 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (Beige 3) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-331-02 1 in 1 BOX 1 NDC:13537-331-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-332 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (Beige 4) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-332-02 1 in 1 BOX 1 NDC:13537-332-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-333 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (Beige 5) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-333-02 1 in 1 BOX 1 NDC:13537-333-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-334 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color BROWN (Beige 6) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-334-02 1 in 1 BOX 1 NDC:13537-334-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-335 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (Rosa 1) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-335-02 1 in 1 BOX 1 NDC:13537-335-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-336 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (Rosa 2) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-336-02 1 in 1 BOX 1 NDC:13537-336-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-337 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (Rosa 3) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-337-02 1 in 1 BOX 1 NDC:13537-337-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-338 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (Rosa 4) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-338-02 1 in 1 BOX 1 NDC:13537-338-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-339 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (Rosa 5) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-339-02 1 in 1 BOX 1 NDC:13537-339-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA 3-IN-1 PRO MAKEUP FOUNDATION SPF 20
octinoxate, oxybenzone, and titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-340 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 Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) starch, corn (UNII: O8232NY3SJ) silicon dioxide (UNII: ETJ7Z6XBU4) mica (UNII: V8A1AW0880) ethylhexyl palmitate (UNII: 2865993309) ceresin (UNII: Q1LS2UJO3A) carnauba wax (UNII: R12CBM0EIZ) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) dimethicone (UNII: 92RU3N3Y1O) methylparaben (UNII: A2I8C7HI9T) 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) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) ferric oxide yellow (UNII: EX438O2MRT) ferric oxide red (UNII: 1K09F3G675) ferrosoferric oxide (UNII: XM0M87F357) Product Characteristics Color RED (Rosa 6) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-340-02 1 in 1 BOX 1 NDC:13537-340-01 6 g in 1 CASE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 Labeler - Ventura Corporation (San Juan, P.R) (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE
