FDA.reportPublic FDA data

whitening cream

Manufacturer
Shenzhen XiaoMai Manufacturing Co., Ltd.
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:51

Label at a glance#

Productwhitening cream
Active ingredientARBUTIN
Label structure12 sections

Dosage and administration

Apply once in the morning and once in the evening; adjust frequency as needed based on skin condition.

Storage and handling

Store in a cool, dry place, avoid direct sunlight.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Arbutin 3%

PURPOSE

OTC - PURPOSE SECTION

Primarily used to improve uneven skin tone and reduce dark spots, making the skin look brighter and more even.

INDICATIONS

INDICATIONS & USAGE SECTION

Used to brighten skin tone and reduce dark spots for a more even and luminous complexion.

Warnings

WARNINGS SECTION


on damaged or broken skin.

Do not use

OTC - STOP USE SECTION

keep out of eyes.
Rinse with water to remove.

When using this product

OTC - WHEN USING SECTION


if rash occurs.

Stop use and ask a doctor

OTC - STOP USE SECTION


If swallowed, get medicalhelp or contact a Poison Control Center right away.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Apply once in the morning and once in the evening; adjust frequency as needed based on skin condition.

Directions for use

DOSAGE & ADMINISTRATION SECTION

Apply once in the morning and once in the evening; adjust frequency as needed based on skin condition.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Aqua 68%
Glycerin 8%
Sodium Hyaluronate 1.5%
Stearyl Alcohol 2%
Propanediol 5%
Hydrogenated Lecithin 1.5%
Squalane 10%
Retinol 1%

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry place, avoid direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83872-199WHITENING CREAM CREAM [SHENZHEN XIAOMAI MANUFACTURING CO., LTD.]1Unmatched20240701_1bc3d631-7436-655f-e063-6394a90ae559.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83872-19983872-199-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALANEGW89575KF9IACT
PROPANEDIOL5965N8W85TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
RETINOLG2SH0XKK91IACT
ARBUTINC5INA23HXFACTIB

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
36573c9c-61c4-bc34-e063-6394a90afc871bc3d631-7436-655f-e063-6394a90ae5592025-05-30WarningsExact identifier
spl set id: 1bc3d631-7436-655f-e063-6394a90ae559

Reported adverse events (FAERS/openFDA)#

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