METABOLIC BRIGHTENING BB CUSHION- titanium dioxide, zinc oxide, alpha bisabolol powder 
rootsallo Qwell

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENTS

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

PURPOSE

Sunscreen, Brightening

Uses

Helps to keep the bright skin tone with excellent coverage.

Warnings

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

KEEP OUT OF REACH OF CHILDREN

Directions

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

Other Information

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

Questions

www.rootsallo.com 82-31-429-0588

Inactive ingredients

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 carton

METABOLIC BRIGHTENING BB CUSHION 
titanium dioxide, zinc oxide, alpha bisabolol powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82450-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide11.51 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.75 g  in 100 mL
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) (.ALPHA.-BISABOLOL, (+/-)- - UNII:36HQN158VC) .ALPHA.-BISABOLOL, (+/-)-0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Isoamyl Laurate (UNII: M1SLX00M3M)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82450-010-021 in 1 CARTON12/01/2021
1NDC:82450-010-0115 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2021
Labeler - rootsallo Qwell (695495466)
Registrant - rootsallo Qwell (695495466)
Establishment
NameAddressID/FEIBusiness Operations
Elan Cosmetic Co.,ltd688204926manufacture(82450-010)

Revised: 12/2021
Document Id: 4b7a7773-4a83-409b-aa3a-07525c9a7fcc
Set id: f43b7112-1034-460f-bcca-7a3b4f325315
Version: 1
Effective Time: 20211230
 
rootsallo Qwell