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

Esika Pro Hydra Smart Hydro-nutritive foundation SPF 15 230-N by

Drug Labeling and Warnings

Esika Pro Hydra Smart Hydro-nutritive foundation SPF 15 230-N by is a Otc medication manufactured, distributed, or labeled by BEL STAR S.A., Bel Star S.A.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobezone 1.80% Sunscreen

Octocrylene 4.5% Sunscreen

Octisalate 4.5% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

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

DOSAGE & ADMINISTRATION

• 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydra-nutritive foundation SPF 15

0.95 fl oz e (28 ml)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14141-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14141-048-01	28 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/10/2019

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

Labeler - BEL STAR S.A. (COLOMBIA) (880160197)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	manufacture(14141-048)