FDA.reportPublic FDA data

iUNIK Centella Calming Daily Sunscreen

Manufacturer
IUNIK Co., Ltd. | YEGREENA CO.,LTD.
Effective date
2023-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:32:47

Label at a glance#

ProductiUNIK Centella Calming Daily Sunscreen
Active ingredientDIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, ETHYLHEXYL TRIAZONE, BISOCTRIZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diethylamino Hydroxybenzoyl Hexyl Benzoate 5%

Ethylhexyl Triazone 4%

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol 2%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Helps prevent sunburn

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

WARNINGS SECTION

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

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

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

INACTIVE INGREDIENT SECTION

Centella Asiatica Extract, Water, Dibutyl Adipate, Glycerin, Niacinamide, Polymethyl Methacrylate, Polysilicone-15, 1,2-Hexanediol, Beta-Glucan, Allantoin, Butylene Glycol, Pentylene Glycol, Arachidyl Alcohol, Sodium Stearoyl Glutamate, Polyglyceryl-3 Methylglucose Distearate, Sorbitan Sesquioleate, Behenyl Alcohol, Decyl Glucoside, Caprylyl Glycol, Arachidyl Glucoside, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Polyacrylate Crosspolymer-6, Adenosine, Dipotassium Glycyrrhizate, Glucose, t-Butyl Alcohol, Xanthan Gum, Tromethamine, Disodium EDTA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83403-00183403-001-01, 83403-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
WATER059QF0KO0RIACT
DIBUTYL ADIPATEF4K100DXP3IACT
GLYCERINPDC6A3C0OXIACT
NIACINAMIDE25X51I8RD4IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
POLYSILICONE-15F8DRP5BB29IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALLANTOIN344S277G0ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PENTYLENE GLYCOL50C1307PZGIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATEW19EIO0DBEIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
DOCOSANOL9G1OE216XYIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
ADENOSINEK72T3FS567IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
ANHYDROUS DEXTROSE5SL0G7R0OKIACT
XANTHAN GUMTTV12P4NEEIACT
TROMETHAMINE023C2WHX2VIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20ACTIB
ETHYLHEXYL TRIAZONEXQN8R9SAK4ACTIB
BISOCTRIZOLE8NT850T0YSACTIB

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
1034a694-0f0a-c3cd-e063-6294a90a76f171d04df1-e34e-48ea-b544-80b0dcfa021a2024-01-30WarningsExact identifier
spl set id: 71d04df1-e34e-48ea-b544-80b0dcfa021a

Reported adverse events (FAERS/openFDA)#

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