ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 330-C- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 410-N- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 390-N- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 430-N- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 320-C- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 160-N- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 230-N- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 450-C- octinoxate, zinc oxide cream
ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 140-C- octinoxate, zinc oxide cream
BEL STAR S.A.

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.

----------

Esika Pro Hydra Smart Hydro-nutritive foundation SPF 15

Active Ingredients Purpose

Avobezone 1.80% Sunscreen

Octocrylene 4.5% Sunscreen

Octisalate 4.5% Sunscreen

Uses

Helps prevent sunburn

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

Stop use and ask a doctor if rash occurs

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 sunburn, not skin cancer or early skin aging.

For external use only.

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

Apply liberally 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.

Inactive ingredients:

Dimethicone, water, PEG-10 dimethicone, isododecane, glycerin, polymethylsilsesquioxane, peg/ppg-18/18 dimethicone, hdi/trimethylol hexyllactone crosspolymer, hydroxyethyl urea, polymethylsilsesquioxane/trimethylsiloxysilicate, polysilicone-11, Zea Mays (corn) starch, sodium pca, dimethicone/vinyl dimethicone crosspolymer, silica, phenoxyethanol, sorbitan sesquioleate, tocopheryl acetate, methylpropanediol, caprylyl glycol, chlorphenesin, disteardimonium hectorite, silanediol salicylate, pisum sativum (pea) extract extract, tromethamine, peg-8 caprylic/capric glycerides, octyldodeceth-25, sodium hyaluronate, propylene glycol, decylene.

May contain titanium, iron oxides, triethoxycaprylylsilane

Esika Pro

HYDRA SMART

hydr0-nutritive foundation SPF 15 140-C

0.95 fl oz e (28 ml)

Hydrasmart

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 160-N

0.95 fl oz e (28 ml)

Hydra smart 160N

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 230-N

0.95 fl oz e (28 ml)

Hydrasmart 230N

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 320-C

0.95 fl oz e (28 ml)

Hydrasmart 320C

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 330-C

0.95 fl oz e (28 ml)

Hydrasmart 5

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 390-N

0.95 fl oz e (28 ml)

Hydrasmart 6

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 410-N

0.95 fl oz e (28 ml)

Hydrasmart 7

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 430-N

0.95 fl oz e (28 ml)

Hydrasmart 8

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 450-C

0.95 fl oz e (28 ml)

Hydrasmart 9

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 330-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-054
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-054-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 410-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-056
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-056-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 390-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-055
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-055-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 430-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-057
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-057-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 320-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-053
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-053-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 160-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-051
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-051-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 230-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-052
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-052-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 450-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-058
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-058-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

ESIKA PRO HYDRA SMART HYDRO-NUTRITIVE FOUNDATION SPF 15 140-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:14141-049
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.065 g in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.33 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEA (UNII: W4X7H8GYFM)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ISODODECANE (UNII: A8289P68Y2)
STARCH, CORN (UNII: O8232NY3SJ)
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 8 (UNII: 00BT03FSO2)
TROMETHAMINE (UNII: 023C2WHX2V)
OCTYLDODECETH-25 (UNII: F8934HEL3M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DECYLENE GLYCOL (UNII: S57M60MI88)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-049-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/10/2019	01/01/2021

Labeler - BEL STAR S.A. (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A.		880160197	manufacture(14141-049, 14141-051, 14141-052, 14141-053, 14141-054, 14141-055, 14141-056, 14141-057, 14141-058)

Revised: 1/2021

Document Id: b841ce2e-ef50-4a98-e053-2995a90ada51

Set id: 995e5687-d5e0-43a2-e053-2995a90ae523

Version: 3

Effective Time: 20210106

BEL STAR S.A.