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 
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25 MEDIO 5 - BEIGE- octinoxate and zinc oxide lotion 
Ventura International LTD

----------

ÉSIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25

Drug Facts

Active IngredientsPurpose
OCTINOXATE 6.5 %Sunscreen
ZINC OXIDE 3.5 %Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

  • Skin Cancer / Skin Aging Alert:Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, notskin cancer or early skin aging.
  • For external use only.

  • Do not useon damaged or broken skin.

  • When using this productkeep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor ifrash occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: Ask a doctor.

Other information

  • Protect the product in this container from excessive heat and direct sun

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.

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami,
FL 33126.

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 1 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 2 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - CLARO 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 1 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 2 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 3 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 3 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 4 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 4 - BEIGE

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 5 - BEIGE

ésika
PRO

INSTANT PERFECTION
3 EN 1

Face Refining Foundation
SPF 25

Net Wt. 1 oz e (30 g)

PRINCIPAL DISPLAY PANEL - 30 g Tube Box - MEDIO 5 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 1 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 2 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - CLARO 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 1 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 2 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 3 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 3 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 4 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 4 - BEIGE

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 5 - BEIGE

ésika
PRO

INSTANT
PERFECTION 3 EN 1

Face Refining
Foundation SPF 25

Net Wt. 0.10 oz. e (3 g)

PRINCIPAL DISPLAY PANEL - 3 g Tube Box - MEDIO 5 - BEIGE
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  CLARO 1 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-064
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-064-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-064-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  CLARO 2 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-065
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-065-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-065-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 1 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-066
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-066-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-066-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 2 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-067-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-067-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 3 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-068
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-068-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-068-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 4 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-069-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-069-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 5 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-070-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-070-0130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  CLARO 1 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-071-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-071-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  CLARO 2 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-073
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-073-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-073-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 1 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-074-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-074-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 2 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-075
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-075-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-075-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 3 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-076
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-076-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-076-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 4 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-078-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-078-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
ESIKA PRO INSTANT PERFECTION 3 EN 1 FACE REFINING FOUNDATION SPF 25  MEDIO 5 - BEIGE
octinoxate and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-079
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.065 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.036 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-079-021 in 1 BOX12/16/201612/31/2021
1NDC:14783-079-013 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/16/201612/31/2021
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(14783-065, 14783-064, 14783-066, 14783-067, 14783-068, 14783-069, 14783-070, 14783-071, 14783-073, 14783-074, 14783-075, 14783-076, 14783-078, 14783-079)

Revised: 5/2025
Document Id: 3492cc7d-7a9c-ea4f-e063-6394a90ad1cc
Set id: d2a23f07-b398-441c-aa9f-1f8288689023
Version: 2
Effective Time: 20250507
 
Ventura International LTD