FDA.reportPublic FDA data

Esika Pro Hydra Smart Hydro-nutritive foundation SPF 15

Manufacturer
BEL STAR S.A.
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:25:41

Label at a glance#

ProductEsika Pro Hydra Smart Hydro-nutritive foundation SPF 15 140-C
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Avobezone 1.80% Sunscreen

Octocrylene 4.5% Sunscreen

Octisalate 4.5% Sunscreen

OTC - PURPOSE SECTION

Uses

  • Helps prevent sunburn

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

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 SECTION

  • 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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydr0-nutritive foundation SPF 15 140-C

0.95 fl oz e (28 ml)

HydrasmartHydrasmart

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 160-N

0.95 fl oz e (28 ml)

Hydra smart 160NHydra smart 160N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 230-N

0.95 fl oz e (28 ml)

Hydrasmart 230NHydrasmart 230N

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 320-C

0.95 fl oz e (28 ml)

Hydrasmart 320CHydrasmart 320C

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 330-C

0.95 fl oz e (28 ml)

Hydrasmart 5Hydrasmart 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 390-N

0.95 fl oz e (28 ml)

Hydrasmart 6Hydrasmart 6

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 410-N

0.95 fl oz e (28 ml)

Hydrasmart 7Hydrasmart 7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 430-N

0.95 fl oz e (28 ml)

Hydrasmart 8Hydrasmart 8

Hydrasmart 8Hydrasmart 8

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esika Pro

HYDRA SMART

hydro-nutritive foundation SPF 15 450-C

0.95 fl oz e (28 ml)

Hydrasmart 9Hydrasmart 9

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-04914141-049-01
14141-05114141-051-01
14141-05214141-052-01
14141-05314141-053-01
14141-05414141-054-01
14141-05514141-055-01
14141-05614141-056-01
14141-05714141-057-01
14141-05814141-058-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 8 · 315 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GLYCERINPDC6A3C0OXIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB
PEAW4X7H8GYFMIACT
CHLORPHENESINI670DAL4SZIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SILANEDIOL SALICYLATEC054DF30K0IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
PEG-10 DIMETHICONE (600 CST)8PR7V1SVM0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ISODODECANEA8289P68Y2IACT
STARCH, CORNO8232NY3SJIACT
CAPRYLOCAPROYL POLYOXYLGLYCERIDES 800BT03FSO2IACT
TROMETHAMINE023C2WHX2VIACT
OCTYLDODECETH-25F8934HEL3MIACT
HYALURONATE SODIUMYSE9PPT4THIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DECYLENE GLYCOLS57M60MI88IACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
METHYLPROPANEDIOLN8F53B3R4RIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMERWB5K9Y35Y9IACT
HYDROXYETHYL UREAMBQ7DDQ7ARIACT
GLYCERINPDC6A3C0OXIACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b841ce2e-ef50-4a98-e053-2995a90ada51995e5687-d5e0-43a2-e053-2995a90ae5232021-01-06WarningsExact identifier
spl set id: 995e5687-d5e0-43a2-e053-2995a90ae523

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.