Label: ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 1) - BROWN- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 2) - BROWN- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 3) - BROWN- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 4) - BROWN- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 5) - BROWN- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 6) - BROWN- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 1) - PINK- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 2) - PINK- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 3) - PINK- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 4) - PINK- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 5) - PINK- octinoxate and oxybenzone emulsion
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 6) - PINK- octinoxate and oxybenzone emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-625-01, 13537-625-02, 13537-626-03, 13537-626-04, view more13537-627-05, 13537-627-06, 13537-628-07, 13537-628-08, 13537-629-09, 13537-629-10, 13537-630-11, 13537-630-12, 13537-631-13, 13537-631-14, 13537-632-15, 13537-632-16, 13537-633-17, 13537-633-18, 13537-634-19, 13537-634-20, 13537-635-21, 13537-635-22, 13537-636-23, 13537-636-24 - 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 November 29, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
-
Directions
- Apply liberally and evenly 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating.
- Reapply at least every 2 hours.
- Children under 6 months of age: Ask a doctor
- Reapply at least every 2 hours.
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- Other information
-
Inactive ingredients
WATER, CYCLOMETHICONE, CYCLOPENTASILOXANE, TALC, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PISUM SATIVUM (PEA) EXTRACT, PEG-12 DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, ISOSTEARYL NEOPENTANOATE, DISTEARDIMONIUM HECTORITE, CYCLOHEXASILOXANE, HYDROXYACETOPHENONE, ROSA CENTIFOLIA FLOWER WATER, SODIUM CHLORIDE, PHENOXYETHANOL, MANNITOL, DIMETHICONE, PROPYLENE CARBONATE, PROPYLENE GLYCOL, OCTYLDODECANOL, BUTYLENE GLYCOL, DIMETHICONOL, CAPRYLYL GLYCOL, CETEARYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, CHLORPHENESIN, MICROCRYSTALLINE WAX, POLYMETHYLSILSESQUIOXANE, PETROLATUM, PHOSPHOLIPIDS, CYCLODEXTRIN, CHOLESTEROL, YEAST EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA ) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, DISODIUM SUCCINATE.
MAY CONTAIN:
TITANIUM DIOXIDE, METHICONE, IRON OXIDES.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 1) - Brown
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 2) - Brown
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 3) - Brown
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 4) - Brown
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 5) - Brown
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 6) - Brown
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 1) - Pink
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 2) - Pink
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 3) - Pink
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 4) - Pink
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 5) - Pink
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 6) - Pink
-
INGREDIENTS AND APPEARANCE
ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 Â (BEIGE 1) - BROWN
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-625 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-625-02 1 in 1 BOX 03/06/2015 1 NDC:13537-625-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 2) - BROWN
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-626 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-626-04 1 in 1 BOX 03/06/2015 1 NDC:13537-626-03 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 3) - BROWN
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-627 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-627-06 1 in 1 BOX 03/06/2015 1 NDC:13537-627-05 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 4) - BROWN
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-628 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-628-08 1 in 1 BOX 03/06/2015 1 NDC:13537-628-07 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 5) - BROWN
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-629 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-629-10 1 in 1 BOX 03/06/2015 1 NDC:13537-629-09 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (BEIGE 6) - BROWN
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-630 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-630-12 1 in 1 BOX 03/06/2015 1 NDC:13537-630-11 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 1) - PINK
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-631 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-631-14 1 in 1 BOX 03/06/2015 1 NDC:13537-631-13 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 2) - PINK
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-632 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-632-16 1 in 1 BOX 03/06/2015 1 NDC:13537-632-15 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 3) - PINK
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-633 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-633-18 1 in 1 BOX 03/06/2015 1 NDC:13537-633-17 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 4) - PINK
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-634 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-634-20 1 in 1 BOX 03/06/2015 1 NDC:13537-634-19 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 5) - PINK
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-635 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-635-22 1 in 1 BOX 03/06/2015 1 NDC:13537-635-21 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15  (ROSA 6) - PINK
octinoxate and oxybenzone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-636 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.05 g  in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.02 g  in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R)  CYCLOMETHICONE (UNII: NMQ347994Z)  CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  TALC (UNII: 7SEV7J4R1U)  POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  PEA (UNII: W4X7H8GYFM)  HEXYL LAURATE (UNII: 4CG9F9W01Q)  ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  CYCLOMETHICONE 6 (UNII: XHK3U310BA)  ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)  SODIUM CHLORIDE (UNII: 451W47IQ8X)  PHENOXYETHANOL (UNII: HIE492ZZ3T)  MANNITOL (UNII: 3OWL53L36A)  DIMETHICONE (UNII: 92RU3N3Y1O)  PROPYLENE CARBONATE (UNII: 8D08K3S51E)  PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  OCTYLDODECANOL (UNII: 461N1O614Y)  BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  CAPRYLYL GLYCOL (UNII: 00YIU5438U)  .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  CHLORPHENESIN (UNII: I670DAL4SZ)  MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  PETROLATUM (UNII: 4T6H12BN9U)  LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  CHOLESTEROL (UNII: 97C5T2UQ7J)  YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  CANDELILLA WAX (UNII: WL0328HX19)  YELLOW WAX (UNII: 2ZA36H0S2V)  CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  CARNAUBA WAX (UNII: R12CBM0EIZ)  POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)  TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  FERRIC OXIDE RED (UNII: 1K09F3G675)  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-636-24 1 in 1 BOX 03/06/2015 1 NDC:13537-636-23 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 03/06/2015 Labeler - Ventura Corporation LTD (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE(13537-625, 13537-626, 13537-627, 13537-628, 13537-629, 13537-630, 13537-631, 13537-632, 13537-633, 13537-634, 13537-635, 13537-636)
