ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  CLEAR 1 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  CLEAR 2 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  MEDIUM 1 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  MEDIUM 2 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  MEDIUM 3 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  MEDIUM 4 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15  MEDIUM 5 - BEIGE- octinoxate, titanium dioxide, and zinc oxide powder 
Ventura Corporation LTD

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.

----------

Ésika Pro Compact Powder High Definition and Double Finish SPF 15

Drug Facts

Active IngredientsPurpose
OCTINOXATE 3%Sunscreen
TITANIUM DIOXIDE 6.24%Sunscreen
ZINC OXIDE 4.9%Sunscreen

Uses

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, not skin cancer or early skin aging.

  • For external use only.

  • Do not use on damaged or broken skin.

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

  • Stop use and ask a doctor if rash occurs.

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

Directions

Other information

Inactive ingredients

MICA, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, MAGNESIUM STEARATE, TRIMETHYLSILOXYSILICATE, ISOSTEARYL NEOPENTANOATE, HYDROGEN DIMETHICONE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, ALUMINA, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN. MAY CONTAIN : IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499).

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - CLEAR 1 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - CLEAR 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - CLEAR 2 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - CLEAR 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 1 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 1 - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 2 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 2 - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 3 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 3 - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 4 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 4 - BEIGE

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 5 - BEIGE

ésika
PRO

POLVOS HD
Compact powder high definition and double finish SPF 15

Net Wt. 0.21 oz. e (6 g)

PRINCIPAL DISPLAY PANEL - 6 g Bottle Box - MEDIUM 5 - BEIGE
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   CLEAR 1 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0054-21 in 1 BOX04/16/2017
1NDC:43596-0054-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   CLEAR 2 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0055-21 in 1 BOX04/16/2017
1NDC:43596-0055-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   MEDIUM 1 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0056-21 in 1 BOX04/16/2017
1NDC:43596-0056-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   MEDIUM 2 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0057
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0057-21 in 1 BOX04/16/2017
1NDC:43596-0057-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   MEDIUM 3 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0058-21 in 1 BOX04/16/2017
1NDC:43596-0058-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   MEDIUM 4 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0059
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0059-21 in 1 BOX04/16/2017
1NDC:43596-0059-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
ESIKA PRO COMPACT HIGH DEFININTION AND DOUBLE FINISH SPF 15   MEDIUM 5 - BEIGE
octinoxate, titanium dioxide, and zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.0624 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0060-21 in 1 BOX04/16/2017
1NDC:43596-0060-16 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35204/16/2017
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(43596-0054, 43596-0055, 43596-0056, 43596-0057, 43596-0058, 43596-0059, 43596-0060)

Revised: 4/2017
Document Id: ab40e923-55be-442d-bbdf-2a4d16c91e63
Set id: 7cc0a280-b108-47ec-9aa2-a111253006d3
Version: 1
Effective Time: 20170421
 
Ventura Corporation LTD