FDA.reportPublic FDA data

METABOLIC BRIGHTENING TONE UP

Manufacturer
rootsallo Qwell | Elan Cosmetic Co.,ltd
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:05

Label at a glance#

ProductMETABOLIC BRIGHTENING TONE UP
Active ingredientAdenosine, .ALPHA.-BISABOLOL, (+/-)-
Label structure10 sections

Indications and uses

Multi-cream, which can help to have a whitening effect and works as a makeup base, maintains a bright and clear skin tone.

Dosage and administration

Use this product as the last step in your skincare routine or as the first step in your makeup routine. Apply an appropriate amount evenly with fingertips.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Adenosine 0.04%
.ALPHA.-BISABOLOL, (+/-)- 0.5%

PURPOSE

OTC - PURPOSE SECTION

Anti wrinkle, Skin Brightening

Uses

INDICATIONS & USAGE SECTION

Multi-cream, which can help to have a whitening effect and works as a makeup base, maintains a bright and clear skin tone.

Warnings

WARNINGS SECTION

For external use only.
In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.
Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

Use this product as the last step in your skincare routine or as the first step in your makeup routine.
Apply an appropriate amount evenly with fingertips.

Other Information

OTHER SAFETY INFORMATION

Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Dicaprylyl Carbonate, Persea Gratissima (Avocado) Oil, Propanediol, Polyglyceryl-3 Polyricinoleate, Caprylic/Capric Triglyceride, Sorbitan Olivate, Titanium Dioxide, Hydrogenated Olive Oil, Butyrospermum Parkii (Shea) Butter, Sodium Chloride, Olea Europaea (Olive) Fruit Oil, Glycerin, Glyceryl Caprylate, Scutellaria Baicalensis Root Extract, Chamaecyparis Obtusa Oil, Glycyrrhiza Inflata Root Extract, Ultramarines, Magnesium Stearate, Olea Europaea (Olive) Oil Unsaponifiables, Tocopherol, Lauroyl Lysine, Paeonia Suffruticosa Root Extract, Mica, Aluminum Hydroxide, Arginine, Sodium Hyaluronate, p-Anisic Acid, Beta-Glucan, *Limonene (essential oil component)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADENOSINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82450-030-022023-01-30C16284748780-1f386c64a-2a8d-0266-e053-dadaa90a7c1a8078edb8-dd69-4e38-b4f2-ca579edbb67e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82450-030-01METABOLIC BRIGHTENING TONE UP50 mL in 1 CONTAINERCREAM501
82450-030-02METABOLIC BRIGHTENING TONE UP1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82450-030METABOLIC BRIGHTENING TONE UP (ADENOSINE, ALPHA BISABOLOL) CREAM [ROOTSALLO QWELL]1Legacy NDC, 2 package rows20211231_8078edb8-dd69-4e38-b4f2-ca579edbb67e.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82450-03082450-030-01, 82450-030-02

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
NameUNIIKind
AdenosineK72T3FS567ACTIB
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCACTIB
Water059QF0KO0RIACT
Dicaprylyl Carbonate609A3V1SUAIACT
AVOCADO OIL6VNO72PFC1IACT

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
d00fbcc9-9214-4e4e-9290-17206728f6a98078edb8-dd69-4e38-b4f2-ca579edbb67e2021-12-30WarningsExact identifier
spl id: d00fbcc9-9214-4e4e-9290-17206728f6a9
spl set id: 8078edb8-dd69-4e38-b4f2-ca579edbb67e

Reported adverse events (FAERS/openFDA)#

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