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

hydra-nutritive foundation SPF 15

0.95 fl oz e (28 ml)

Hydrasmart

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0136
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
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CHLORPHENESIN (UNII: I670DAL4SZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
PEA (UNII: W4X7H8GYFM)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
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)
HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
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 100 (UNII: RO266O364U)
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)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0136-1	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

Labeler - Ventura Corporation Limited (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	manufacture(43596-0136)