Label: ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE- octinoxate and zinc oxide lotion
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE- octinoxate and zinc oxide lotion
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE- octinoxate and zinc oxide lotion
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE- octinoxate and zinc oxide lotion
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE- octinoxate and zinc oxide lotion
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE- octinoxate and zinc oxide lotion
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE- octinoxate and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 14783-064-01, 14783-064-02, 14783-065-01, 14783-065-02, view more14783-066-01, 14783-066-02, 14783-067-01, 14783-067-02, 14783-068-01, 14783-068-02, 14783-069-01, 14783-069-02, 14783-070-01, 14783-070-02, 14783-071-01, 14783-071-02, 14783-073-01, 14783-073-02, 14783-074-01, 14783-074-02, 14783-075-01, 14783-075-02, 14783-076-01, 14783-076-02, 14783-078-01, 14783-078-02, 14783-079-01, 14783-079-02 - Packager: Ventura International LTD
- 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 December 29, 2016
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 INGREDIENT
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
ISODODECANE, DIMETHICONE, POLYSILICONE-11, WATER, ZEA MAYS (CORN) STARCH, PEG-10 DIMETHICONE, GLYCERIN, BENZIMIDAZOLE DIAMOND AMIDOETHYL UREA CARBAMOYL PROPYL POLYMETHYLSILSESQUIOXANE, ALUMINA, SILICA, POLYMETHYLSILSESQUIOXANE, BENTONITE, PHENOXYETHANOL, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, METHYLPROPANEDIOL, TOCOPHERYL ACETATE, CAPRYLYL GLYCOL, CHLORPHENESIN, TRIETHOXYCAPRYLYLSILANE, SILANEDIOL SALICYLATE, OLIVE OIL DECYL ESTERS, TROMETHAMINE, LAURETH-12, CERAMIDE 3, CITRIC ACID, HYDRATED SILICA, LACTIC ACID, SQUALENE, CHLORELLA VULGARIS EXTRACT, SEA SALT, TOCOPHEROL. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES, MICA.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 3 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 4 - BEIGE
- PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 5 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 1 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 2 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 3 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 4 - BEIGE
- PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 5 - BEIGE
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INGREDIENTS AND APPEARANCE
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-064 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-064-02 1 in 1 BOX 12/16/2016 1 NDC:14783-064-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-065 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-065-02 1 in 1 BOX 12/16/2016 1 NDC:14783-065-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-066 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-066-02 1 in 1 BOX 12/16/2016 1 NDC:14783-066-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-067 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-067-02 1 in 1 BOX 12/16/2016 1 NDC:14783-067-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-068 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-068-02 1 in 1 BOX 12/16/2016 1 NDC:14783-068-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-069 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-069-02 1 in 1 BOX 12/16/2016 1 NDC:14783-069-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-070 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-070-02 1 in 1 BOX 12/16/2016 1 NDC:14783-070-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 1 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-071 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-071-02 1 in 1 BOX 12/16/2016 1 NDC:14783-071-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 CLARO 2 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-073 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-073-02 1 in 1 BOX 12/16/2016 1 NDC:14783-073-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 1 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-074 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-074-02 1 in 1 BOX 12/16/2016 1 NDC:14783-074-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 2 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-075 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-075-02 1 in 1 BOX 12/16/2016 1 NDC:14783-075-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 3 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-076 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-076-02 1 in 1 BOX 12/16/2016 1 NDC:14783-076-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 4 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-078 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-078-02 1 in 1 BOX 12/16/2016 1 NDC:14783-078-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE
octinoxate and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-079 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 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.036 g in 1 g Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) DIMETHICONE (UNII: 92RU3N3Y1O) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) GLYCERIN (UNII: PDC6A3C0OX) ALUMINUM OXIDE (UNII: LMI26O6933) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) BENTONITE (UNII: A3N5ZCN45C) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) METHYLPROPANEDIOL (UNII: N8F53B3R4R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHLORPHENESIN (UNII: I670DAL4SZ) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SILANEDIOL SALICYLATE (UNII: C054DF30K0) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) TROMETHAMINE (UNII: 023C2WHX2V) LAURETH-12 (UNII: OAH19558U1) CERAMIDE NP (UNII: 4370DF050B) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDRATED SILICA (UNII: Y6O7T4G8P9) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) SQUALENE (UNII: 7QWM220FJH) CHLORELLA VULGARIS (UNII: RYQ4R60M02) SEA SALT (UNII: 87GE52P74G) TOCOPHEROL (UNII: R0ZB2556P8) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE RED (UNII: 1K09F3G675) MICA (UNII: V8A1AW0880) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14783-079-02 1 in 1 BOX 12/16/2016 1 NDC:14783-079-01 3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 12/16/2016 Labeler - Ventura International LTD (603192787) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(14783-064, 14783-065, 14783-066, 14783-067, 14783-068, 14783-069, 14783-070, 14783-071, 14783-073, 14783-074, 14783-075, 14783-076, 14783-078, 14783-079)
