​YEGREENA - 43 83403-001_iUNIK Centella Calming Daily Sunscreen

iUNIK Centella Calming Daily Sunscreen by

Drug Labeling and Warnings

iUNIK Centella Calming Daily Sunscreen by is a Otc medication manufactured, distributed, or labeled by IUNIK Co., Ltd., YEGREENA CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IUNIK CENTELLA CALMING DAILY SUNSCREEN- diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol cream 
IUNIK Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

​YEGREENA - 43
83403-001_iUNIK Centella Calming Daily Sunscreen

Diethylamino Hydroxybenzoyl Hexyl Benzoate 5%

Ethylhexyl Triazone 4%

Methylene Bis-Benzotriazolyl Tetramethylbutylphenol 2%

Sunscreen

Helps prevent sunburn

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

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

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

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

IUNIK CENTELLA CALMING DAILY SUNSCREEN 
diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83403-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE	5 g  in 100 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE - UNII:ANQ870JD20)	ETHYLHEXYL TRIAZONE	4 g  in 100 mL
BISOCTRIZOLE (UNII: 8NT850T0YS) (BISOCTRIZOLE - UNII:8NT850T0YS)	BISOCTRIZOLE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
NIACINAMIDE (UNII: 25X51I8RD4)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
POLYSILICONE-15 (UNII: F8DRP5BB29)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE (UNII: W19EIO0DBE)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
DOCOSANOL (UNII: 9G1OE216XY)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
ADENOSINE (UNII: K72T3FS567)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
XANTHAN GUM (UNII: TTV12P4NEE)
TROMETHAMINE (UNII: 023C2WHX2V)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
WATER (UNII: 059QF0KO0R)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83403-001-02	1 in 1 CARTON	04/18/2023
1	NDC: 83403-001-01	60 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/18/2023	01/01/2024

Labeler - IUNIK Co., Ltd. (695653625)

Registrant - IUNIK Co., Ltd. (695653625)

Establishment
Name	Address	ID/FEI	Business Operations
YEGREENA CO.,LTD.		695951904	manufacture(83403-001)

Revised: 1/2024

Document Id: 1034a694-0f0a-c3cd-e063-6294a90a76f1

34390-5

Set id: 71d04df1-e34e-48ea-b544-80b0dcfa021a

Version: 2

Effective Time: 20240130