Label: ESIKA- octinoxate and oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-305-01, 13537-305-02, 13537-306-01, 13537-306-02, view more13537-307-01, 13537-307-02, 13537-308-01, 13537-308-02, 13537-309-01, 13537-309-02, 13537-310-01, 13537-310-02, 13537-311-01, 13537-311-02, 13537-312-01, 13537-312-02, 13537-313-01, 13537-313-02, 13537-314-01, 13537-314-02, 13537-315-01, 13537-315-02, 13537-316-01, 13537-316-02 - Packager: Ventura Corporation (San Juan, P.R)
- Category: HUMAN OTC DRUG LABEL
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 17, 2011
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aqua (water), cyclomethicone, cyclopentasiloxane, talc, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, pisum sativum (pea) extract), peg-12 dimethicone crosspolymer, hexyl laurate, isostearyl neopentanoate, disteardimonium hectorite, cyclohexasiloxane, rosa centifolia flower water, sodium chloride, mannitol, dimethicone, propylene carbonate, propylene glycol, phenoxyethanol, octyldodecanol, butylene glycol, dimethiconol, methylparaben, propylparaben, cetearyl dimethicone crosspolymer, tocopheryl acetate, microcristallina cera (microcrystalline wax), methicone, polymethylsilsesquioxane, petrolatum, phospholipids, bha, bht, cyclodextrin, butylparaben, ethylparaben, cholesterol, faex extract (yeast extract), isobutylparaben, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), cetearyl alcohol, cetearyl glucoside, copernicia cerifera cera (copernicia cerifera (carnauba) wax), polyglyceryl-2 dipolyhydroxystearate, olea europaea oil unsaponifiables (olea europaea (olive) oil unsaponifiables), glycosphingolipids, disodium succinate. May contain: CI 77891 (titanium dioxide), CI 77492 (iron oxides), CI 77491 (iron oxides), CI 77499 (iron oxides).
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INGREDIENTS AND APPEARANCE
ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-305 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-305-02 1 in 1 BOX 1 NDC:13537-305-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-306-02 1 in 1 BOX 1 NDC:13537-306-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-307 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-307-02 1 in 1 BOX 1 NDC:13537-307-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-308 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-308-02 1 in 1 BOX 1 NDC:13537-308-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-309 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-309-02 1 in 1 BOX 1 NDC:13537-309-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-310 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-310-02 1 in 1 BOX 1 NDC:13537-310-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-311 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-311-02 1 in 1 BOX 1 NDC:13537-311-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-312-02 1 in 1 BOX 1 NDC:13537-312-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-313-02 1 in 1 BOX 1 NDC:13537-313-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-314 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-314-02 1 in 1 BOX 1 NDC:13537-314-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-315 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-315-02 1 in 1 BOX 1 NDC:13537-315-01 30 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 05/17/2011 ESIKA HYDRO-NUTRATIVE FOUNDATION SPF 13
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-316 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone (UNII: NMQ347994Z) cyclomethicone 5 (UNII: 0THT5PCI0R) talc (UNII: 7SEV7J4R1U) polyglyceryl-4 isostearate (UNII: 820DPX33S7) pea (UNII: W4X7H8GYFM) hexyl laurate (UNII: 4CG9F9W01Q) cyclomethicone 6 (UNII: XHK3U310BA) rosa centifolia flower oil (UNII: H32V31VMWY) sodium chloride (UNII: 451W47IQ8X) mannitol (UNII: 3OWL53L36A) dimethicone (UNII: 92RU3N3Y1O) propylene carbonate (UNII: 8D08K3S51E) propylene glycol (UNII: 6DC9Q167V3) phenoxyethanol (UNII: HIE492ZZ3T) octyldodecanol (UNII: 461N1O614Y) butylene glycol (UNII: 3XUS85K0RA) methylparaben (UNII: A2I8C7HI9T) propylparaben (UNII: Z8IX2SC1OH) microcrystalline wax (UNII: XOF597Q3KY) petrolatum (UNII: 4T6H12BN9U) butylated hydroxyanisole (UNII: REK4960K2U) butylated hydroxytoluene (UNII: 1P9D0Z171K) butylparaben (UNII: 3QPI1U3FV8) ethylparaben (UNII: 14255EXE39) cholesterol (UNII: 97C5T2UQ7J) yeast (UNII: 3NY3SM6B8U) isobutylparaben (UNII: 0QQJ25X58G) candelilla wax (UNII: WL0328HX19) yellow wax (UNII: 2ZA36H0S2V) cetostearyl alcohol (UNII: 2DMT128M1S) cetearyl glucoside (UNII: 09FUA47KNA) carnauba wax (UNII: R12CBM0EIZ) olive oil (UNII: 6UYK2W1W1E) sodium succinate anhydrous (UNII: V8ZGC8ISR3) titanium dioxide (UNII: 15FIX9V2JP) 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:13537-316-02 1 in 1 BOX 1 NDC:13537-316-01 30 mL in 1 BOTTLE 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
