Label: ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 CLARO 2/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO1/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO2/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO3/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO4/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 MEDIO5/BEIGE- octinoxate and zinc oxide cream
ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20 CLARO 1/BEIGE- octinoxate and zinc oxide cream

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    14783-171-01, 14783-171-02, 14783-172-01, 14783-172-02, view more
    14783-173-01, 14783-173-02, 14783-174-01, 14783-174-02, 14783-175-01, 14783-175-02, 14783-176-01, 14783-176-02, 14783-177-01, 14783-177-02
  • Packager: Ventura International LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 25, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    OCTINOXATE 5 %Sunscreen
    ZINC OXIDE 4.2 %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

    WATER, DIMETHICONE, ISODODECANE, PEG-10 DIMETHICONE, GLYCERIN, PROPYLENE GLYCOL, POLYMETHYLSILSESQUIOXANE, POLYSILICONE-11, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PEG/PPG-18/18 DIMETHICONE, HYDROXYACETOPHENONE, SILICA DIMETHYL SILYLATE, SODIUM CHLORIDE, PHENOXYETHANOL, SILICA, TOCOPHERYL ACETATE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, CHLORPHENESIN, DISTEARDIMONIUM HECTORITE, TRIETHOXYCAPRYLYLSILANE, SILANEDIOL SALICYLATE, BUTYLENE GLYCOL, TROMETHAMINE, FRAGRANCE, AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, HYDROLYZED WHEAT PROTEIN, SILYBUM MARIANUM FRUIT EXTRACT, LINALOOL, d-LIMONENE, ALPHA-ISOMETHYL IONONE.

    MAY CONTAIN : TITANIUM DIOXIDE, IRON OXIDES.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claro 2/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Claro 2/Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio1/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Medio1/Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio2/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Medio2/Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio3/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Medio3/Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio4/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Medio4/Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Medio5/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Medio5/Beige
  • PRINCIPAL DISPLAY PANEL - 30 g Bottle Box - Claro 1/Beige

    ésika
    PRO

    NATURAL MATTE

    Mattifying foundation
    adaptable to your skin
    tone SPF 20

    Net wt. 1 oz. e (30 g)

    Principal Display Panel - 30 g Bottle Box - Claro 1/Beige
  • INGREDIENTS AND APPEARANCE
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   CLARO 2/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-177-021 in 1 BOX10/19/2018
    1NDC:14783-177-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO1/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-171
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-171-021 in 1 BOX10/19/2018
    1NDC:14783-171-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO2/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-172
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-172-021 in 1 BOX10/19/2018
    1NDC:14783-172-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO3/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-173-021 in 1 BOX10/19/2018
    1NDC:14783-173-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO4/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-174
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-174-021 in 1 BOX10/19/2018
    1NDC:14783-174-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   MEDIO5/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-175
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-175-021 in 1 BOX10/19/2018
    1NDC:14783-175-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    ESIKA PRO NATURAL MATTIFYING FOUNDATION ADAPTABLE TO YOUR SKIN TONE SPF 20   CLARO 1/BEIGE
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-176
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.05 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.042 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISODODECANE (UNII: A8289P68Y2)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)  
    MILK THISTLE (UNII: U946SH95EE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-176-021 in 1 BOX10/19/2018
    1NDC:14783-176-0130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/19/2018
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197manufacture(14783-171, 14783-172, 14783-173, 14783-174, 14783-175, 14783-176, 14783-177)