FDA.reportPublic FDA data

PURITO Comfy Water Sun Block

Manufacturer
HINATURE Inc. | Nowcos.Co.,Ltd
Effective date
2019-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:18:16

Label at a glance#

ProductPURITO Comfy Water Sun Block
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 2.85%
Titanium Dioxide 0.785%

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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

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

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 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73251-00173251-001-01, 73251-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CETYL ETHYLHEXANOATE134647WMX4IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERINPDC6A3C0OXIACT
DIPROPYLENE GLYCOLE107L85C40IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NIACINAMIDE25X51I8RD4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARIC ACID4ELV7Z65APIACT
LAUROYL LYSINE113171Q70BIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ADENOSINEK72T3FS567IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
MADECASSOSIDECQ2F5O6YIYIACT
ASIATICOSIDEPKO39VY215IACT
MADECASSIC ACIDM7O1N24J82IACT
ASIATIC ACID9PA5A687X5IACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
907ce9a9-3179-0d8a-e053-2995a90a80fabeee9be7-0968-45da-81cc-2de99d24682a2019-08-19WarningsExact identifier
spl set id: beee9be7-0968-45da-81cc-2de99d24682a

Reported adverse events (FAERS/openFDA)#

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