73251-001_PURITO Comfy Water Sun Block

Drug Details [pdf]

PURITO COMFY WATER SUN BLOCK- zinc oxide, titanium dioxide cream
HINATURE Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

73251-001_PURITO Comfy Water Sun Block_Deactivation

Zinc Oxide 2.85%
Titanium Dioxide 0.785%

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, Cetyl Ethylhexanoate, Butylene Glycol, Glycerin, Dipropylene Glycol, Silica, Niacinamide, 1,2-Hexanediol, Polyglyceryl-3 MethylglucoseDistearate, Sodium PolyacryloyldimethylTaurate, Cetearyl Olivate, Sorbitan Olivate, Stearic Acid, Lauroyl Lysine, Disodium EDTA, Acrylates/C10-30 Alkyl AcrylateCrosspolymer, Adenosine, Hydroxyethyl Acrylate/SodiumAcryloyldimethyl TaurateCopolymer, Madecassoside, Asiaticoside, Madecassic Acid, Asiatic Acid

image description

PURITO COMFY WATER SUN BLOCK
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73251-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	28.5 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	7.85 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NIACINAMIDE (UNII: 25X51I8RD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARIC ACID (UNII: 4ELV7Z65AP)
LAUROYL LYSINE (UNII: 113171Q70B)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ADENOSINE (UNII: K72T3FS567)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
MADECASSOSIDE (UNII: CQ2F5O6YIY)
ASIATICOSIDE (UNII: PKO39VY215)
MADECASSIC ACID (UNII: M7O1N24J82)
ASIATIC ACID (UNII: 9PA5A687X5)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 73251-001-02	1 in 1 CARTON	07/23/2019	08/19/2019
1	NDC: 73251-001-01	60 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/23/2019	08/19/2019

Labeler - HINATURE Inc. (694862999)

Registrant - HINATURE Inc. (694862999)

Name	Address	ID/FEI	Business Operations
Establishment
Nowcos.Co.,Ltd		689914984	manufacture(73251-001)

Revised: 8/2019

Document Id: 907ce9a9-3179-0d8a-e053-2995a90a80fa

Set id: beee9be7-0968-45da-81cc-2de99d24682a

Version: 2

Effective Time: 20190819

HINATURE Inc.

73251-001_PURITO Comfy Water Sun Block_Deactivation

PURITO Comfy Water Sun Block by

Drug Labeling and Warnings

Drug Details [pdf]

73251-001_PURITO Comfy Water Sun Block_Deactivation