ONALT PURE MILD SUNCREAM

Manufacturer: HnB9 Co., Ltd.
Effective date: 2020-09-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 23:29:53

Label at a glance#

ProductONALT PURE MILD SUNCREAM

Active ingredientTITANIUM DIOXIDE, ZINC OXIDE

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

titanium dioxide, zinc oxide

OTC - PURPOSE SECTION

UV protection

skin whitening

wrinkle care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF THE CHILDREN

WARNINGS SECTION

■ For external use only.

■ Do not use in eyes.

■ lf swallowed, get medical help promptly.

■ Stop use, ask doctor lf irritation occurs.

■ Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

for external use only

INACTIVE INGREDIENT SECTION

Water
C12-15 Alkyl Benzoate
Cyclopentasiloxane
Glycerin
Methylpropanediol
Cetyl PEG/PPG-10/1 Dimethicone
Aluminum Hydroxide
Polyhydroxystearic Acid
Niacinamide
Cetyl Dimethicone
Sea Water
Cetyl Ethylhexanoate
Sorbitan Trioleate
Stearic Acid
Isostearic Acid
Sorbitan Sesquioleate
Trifluoropropyl Dimethicone
Benzyl Glycol
Disteardimonium Hectorite
Ozokerite
Sodium Chloride
Butylene Glycol
Silica Dimethyl Silylate
Polymethylsilsesquioxane
Fragrance
Silica
Tocopheryl Acetate
Sargassum Fulvellum Extract
Ethylhexylglycerin
Hizikia Fusiforme Extract
1,2-Hexanediol
Adenosine
Disodium EDTA
Ethylhexylglycerin

INDICATIONS & USAGE SECTION

apply proper amount to the skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80564-0001-1	2022-01-28	C162847	48780-1	d6a99b39-ca08-a426-e053-dadaa90af4c2	afdd2516-7411-c93c-e053-2995a90a8646

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80564-0001-1	ONALT PURE MILD SUNCREAM	50 mL in 1 TUBE	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80564-0001	ONALT PURE MILD SUNCREAM (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HNB9 CO., LTD.]	1	Legacy NDC, 1 package rows	20200922_afdd2516-7411-c93c-e053-2995a90a8646.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

ONALT PURE MILD SUNCREAM
titanium dioxide, zinc oxide
TITANIUM DIOXIDE
ALUMINUM HYDROXIDE
WATER
GLYCERIN
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
80564-0001	80564-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
afdd5db8-5ad6-f71a-e053-2a95a90a82a5			afdd2516-7411-c93c-e053-2995a90a8646	2020-09-21	Warnings	Exact identifier spl id: afdd5db8-5ad6-f71a-e053-2a95a90a82a5 spl set id: afdd2516-7411-c93c-e053-2995a90a8646

Reported adverse events (FAERS/openFDA)#

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