Label: ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BEIGE 1- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BEIGE 2- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 1- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 YELLOW 1- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 YELLOW 2- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 2- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 3- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 4- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 5- octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 43596-0701-1, 43596-0702-1, 43596-0703-1, 43596-0704-1, view more43596-0705-1, 43596-0706-1, 43596-0707-1, 43596-0708-1, 43596-0709-1 - Packager: Ventura Corporation Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 12, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients:
Dimethicone, water, PEG-10 dimethicone, isododecane, glycerin, polymethylsilsesquioxane, peg/ppg-18/18 dimethicone, hdi/trimethylol hexyllactone crosspolymer, hydroxyethyl urea, polymethylsilsesquioxane/trimethylsiloxysilicate, polysilicone-11, Zea Mays (corn) starch, sodium pca, dimethicone/vinyl dimethicone crosspolymer, silica, phenoxyethanol, sorbitan sesquioleate, tocopheryl acetate, methylpropanediol, caprylyl glycol, chlorphenesin, disteardimonium hectorite, silanediol salicylate, pisum sativum (pea) extract extract, tromethamine, peg-8 caprylic/capric glycerides, octyldodeceth-25, sodium hyaluronate, propylene glycol, decylene.
May contain titanium, iron oxides, triethoxycaprylylsilane
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INGREDIENTS AND APPEARANCE
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BEIGE 1
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0701-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BEIGE 2
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0702 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0702-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 1
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0703-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 YELLOW 1
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0704 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0704-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 YELLOW 2
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0705 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0705-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 2
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0706 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0706-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 3
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0707 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0707-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 4
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0708 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0708-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 BROWN 5
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43596-0709 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.065 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.33 g in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CHLORPHENESIN (UNII: I670DAL4SZ) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILANEDIOL SALICYLATE (UNII: C054DF30K0) PEA (UNII: W4X7H8GYFM) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISODODECANE (UNII: A8289P68Y2) HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) STARCH, CORN (UNII: O8232NY3SJ) CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2) TROMETHAMINE (UNII: 023C2WHX2V) OCTYLDODECETH-25 (UNII: F8934HEL3M) HYALURONATE SODIUM (UNII: YSE9PPT4TH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) DECYLENE GLYCOL (UNII: S57M60MI88) DIMETHICONE 100 (UNII: RO266O364U) WATER (UNII: 059QF0KO0R) METHYLPROPANEDIOL (UNII: N8F53B3R4R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43596-0709-1 28 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/10/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/10/2019 Labeler - Ventura Corporation Limited (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 manufacture(43596-0701, 43596-0702, 43596-0703, 43596-0704, 43596-0705, 43596-0706, 43596-0707, 43596-0708, 43596-0709)
