DailyMed - 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)

Contains inactivated NDC Code(s)
NDC Code(s): 13537-625-01, 13537-625-02, 13537-626-03, 13537-626-04, view more
13537-627-05, 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)

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active Ingredients Purpose

OCTINOXATE: 5.00% Sunscreen

OXYBENZONE: 2.00% Sunscreen
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
- 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.
- 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
- Protect this product in this container form excesive heat and direct sun. Keep away from heat sources and direct sunlight. Store well and under 50°C (112°F).
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

Dist. by Ventura Corp, Ltd., San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 1) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 2) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 3) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 4) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 5) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Beige 6) - Brown

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 1) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 2) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 3) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 4) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 5) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box - (Rosa 6) - Pink

ésika
PRO

Hydro-Nutritive
Foundation
SPF 15

30 ml e (1 fl.oz.)

Active Ingredients	Purpose
OCTINOXATE: 5.00%	Sunscreen
OXYBENZONE: 2.00%	Sunscreen

INGREDIENTS AND APPEARANCE

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 1) - BROWN
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-625
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 2) - BROWN
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-626
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 3) - BROWN
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-627
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 4) - BROWN
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-628
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 5) - BROWN
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-629
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (BEIGE 6) - BROWN
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-630
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 1) - PINK
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-631
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 2) - PINK
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-632
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 3) - PINK
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-633
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 4) - PINK
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-634
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 5) - PINK
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-635
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

ESIKA PRO HYDRO-NUTRITIVE FOUNDATION SPF 15 (ROSA 6) - PINK
octinoxate and oxybenzone emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13537-636
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	03/06/2015

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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Published Date (What is this?)	Version	Files
Dec 5, 2017	3 (current)	download
May 28, 2015	2	download
Mar 16, 2015	1	download

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	NDC
1	13537-625-01
2	13537-625-02 (inactivated)
3	13537-626-03
4	13537-626-04 (inactivated)
5	13537-627-05
6	13537-627-06 (inactivated)
7	13537-628-07
8	13537-628-08 (inactivated)
9	13537-629-09
10	13537-629-10 (inactivated)
11	13537-630-11
12	13537-630-12 (inactivated)
13	13537-631-13
14	13537-631-14 (inactivated)
15	13537-632-15
16	13537-632-16 (inactivated)
17	13537-633-17
18	13537-633-18 (inactivated)
19	13537-634-19
20	13537-634-20 (inactivated)
21	13537-635-21
22	13537-635-22 (inactivated)
23	13537-636-23
24	13537-636-24 (inactivated)

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.