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 1 - BEIGE- octinoxate and zinc oxide lotion 
Ventura Corporation 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 Ventural Corp, Ltd., San Juan, Puerto Rico 00926.

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:13537-853
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:13537-853-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-853-0130 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:13537-854
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:13537-854-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-854-0130 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:13537-855
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
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MICA (UNII: V8A1AW0880)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-855-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-855-0130 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:13537-856
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:13537-856-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-856-0130 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:13537-857
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:13537-857-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-857-0130 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:13537-858
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:13537-858-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-858-0130 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:13537-859
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:13537-859-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-859-0130 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:13537-860
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:13537-860-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-860-013 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:13537-861
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:13537-861-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-861-013 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:13537-862
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:13537-862-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-862-013 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:13537-863
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:13537-863-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-863-013 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:13537-864
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
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-864-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-864-013 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:13537-865
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:13537-865-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-865-013 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:13537-866
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:13537-866-021 in 1 BOX12/16/201612/31/2021
1NDC:13537-866-013 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 Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(13537-853, 13537-854, 13537-855, 13537-856, 13537-857, 13537-858, 13537-859, 13537-860, 13537-861, 13537-862, 13537-863, 13537-864, 13537-865, 13537-866)

Revised: 5/2025
Document Id: 342cad67-9ace-208f-e063-6394a90ae591
Set id: e7f59208-0491-4964-bc6a-34876a4b5523
Version: 2
Effective Time: 20250502
 
Ventura Corporation LTD