Label: 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

  • Contains inactivated NDC Code(s)
    NDC Code(s):     43596-0054-1, 43596-0054-2, 43596-0055-1, 43596-0055-2, view more
    43596-0056-1, 43596-0056-2, 43596-0057-1, 43596-0057-2, 43596-0058-1, 43596-0058-2, 43596-0059-1, 43596-0059-2, 43596-0060-1, 43596-0060-2
  • Packager: Ventura Corporation 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 April 21, 2017

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

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

    • 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

    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).

  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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