73251-002_PURITO Centella Green Level Safe Sun_Deactivation

PURITO Centella Green Level Safe Sun by

Drug Labeling and Warnings

PURITO Centella Green Level Safe Sun by is a Otc medication manufactured, distributed, or labeled by HINATURE Inc., Nowcos.Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURITO CENTELLA GREEN LEVEL SAFE SUN- diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone cream 
HINATURE Inc.

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.

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73251-002_PURITO Centella Green Level Safe Sun_Deactivation

Diethylamino Hydroxybenzoyl Hexyl Benzoate 3.00%
Ethylhexyl Triazone 2.00%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

For external use only.
Do not use on damaged or broken skin.
When using this product, keep out of eyes. Rinse with water to remove.
Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Butylene Glycol, Glycerin, Dicaprylyl Carbonate, Dibutyl Adipate, Hydrogenated Polyisobutene, 1,2-Hexanediol, Niacinamide, Polyglyceryl-3 MethylglucoseDistearate, Silica, Cetearyl Olivate, Cetearyl Alcohol, Sorbitan Olivate, Glyceryl Stearate SE, Methyl Glucose Sesquistearate, Sorbitan Stearate, Centella Asiatica Extract, Lavandula Angustifolia(Lavender) Oil, Disodium EDTA, Adenosine, Anthemis Nobilis Flower Oil, Hyaluronic Acid, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol

PURITO CENTELLA GREEN LEVEL SAFE SUN 
diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73251-002
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	30 mg  in 1 mL
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4)	ETHYLHEXYL TRIAZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
LAVENDER OIL (UNII: ZBP1YXW0H8)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ADENOSINE (UNII: K72T3FS567)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
HYALURONIC ACID (UNII: S270N0TRQY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73251-002-02	1 in 1 CARTON	07/23/2019	08/19/2019
1	NDC: 73251-002-01	60 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/23/2019	08/19/2019

Labeler - HINATURE Inc. (694862999)

Registrant - HINATURE Inc. (694862999)

Establishment
Name	Address	ID/FEI	Business Operations
Nowcos.Co.,Ltd		689914984	manufacture(73251-002)

Revised: 8/2019

Document Id: 907ce9a9-3183-0d8a-e053-2995a90a80fa

34390-5

Set id: c2ede867-e678-433e-89ea-96fd7189d303

Version: 2

Effective Time: 20190819