FDA.reportPublic FDA data

METABOLIC BRIGHTENING BB CUSHION

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 23:46:09

Label at a glance#

ProductMETABOLIC BRIGHTENING BB CUSHION
Active ingredientTitanium Dioxide, Zinc Oxide, .ALPHA.-BISABOLOL, (+/-)-
Label structure10 sections

Indications and uses

Helps to keep the bright skin tone with excellent coverage.

Dosage and administration

Using puff applicator, press down lightly onto pre-saturated cushion sponge to capture product and pat evenly over face.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 11.51%
Zinc Oxide 4.75%
.ALPHA.-BISABOLOL, (+/-)- 0.5%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen, Brightening

Uses

INDICATIONS & USAGE SECTION

Helps to keep the bright skin tone with excellent coverage.

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

Using puff applicator, press down lightly onto pre-saturated cushion sponge to capture product and pat evenly over face.

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, Isoamyl Laurate, Caprylic/Capric Triglyceride, Oenothera Biennis (Evening Primrose) Oil, Macadamia Integrifolia Seed Oil, Polyglyceryl-3 Polyricinoleate, Sorbitan Olivate, Glycerin, Sodium Chloride, Scutellaria Baicalensis Root Extract, Hydrogenated Olive Oil, Propanediol, Glyceryl Caprylate, Lauroyl Lysine, Betaine, Chamaecyparis Obtusa Oil, Olea Europaea (Olive) Fruit Oil, Aluminum Hydroxide, Citric Acid, Magnesium Stearate, Iron Oxide Red, Arginine, Stearic Acid, p-Anisic Acid, Tocopherol, Iron Oxide Black, Olea Europaea (Olive) Oil Unsaponifiables, Mica, Sodium Hyaluronate, Magnesium Palmitate, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Polygonum Cuspidatum Root Extract, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Bioflavonoids, Brassica Oleracea Italica (Broccoli) Extract, *Limonene (essential oil component)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82450-010-022023-01-30C16284748780-1f386c649-ee4e-0266-e053-dadaa90a7c1af43b7112-1034-460f-bcca-7a3b4f325315

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82450-010-01METABOLIC BRIGHTENING BB CUSHION15 mL in 1 CONTAINERPOWDER151
82450-010-02METABOLIC BRIGHTENING BB CUSHION1 in 1 CARTONPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82450-010METABOLIC BRIGHTENING BB CUSHION (TITANIUM DIOXIDE, ZINC OXIDE, ALPHA BISABOLOL) POWDER [ROOTSALLO QWELL]1Legacy NDC, 2 package rows20211231_f43b7112-1034-460f-bcca-7a3b4f325315.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82450-01082450-010-01, 82450-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIM
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCACTIB
Water059QF0KO0RIACT
Isoamyl LaurateM1SLX00M3MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT

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
4b7a7773-4a83-409b-aa3a-07525c9a7fccf43b7112-1034-460f-bcca-7a3b4f3253152021-12-30WarningsExact identifier
spl id: 4b7a7773-4a83-409b-aa3a-07525c9a7fcc
spl set id: f43b7112-1034-460f-bcca-7a3b4f325315

Reported adverse events (FAERS/openFDA)#

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