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

METABOLIC BRIGHTENING BB CUSHION by

Drug Labeling and Warnings

METABOLIC BRIGHTENING BB CUSHION by is a Otc medication manufactured, distributed, or labeled by rootsallo Qwell, Elan Cosmetic Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82450-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	11.51 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	4.75 g  in 100 mL
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) (.ALPHA.-BISABOLOL, (+/-)- - UNII:36HQN158VC)	.ALPHA.-BISABOLOL, (+/-)-	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isoamyl Laurate (UNII: M1SLX00M3M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82450-010-02	1 in 1 CARTON	12/01/2021
1	NDC: 82450-010-01	15 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2021

Labeler - rootsallo Qwell (695495466)

Registrant - rootsallo Qwell (695495466)

Establishment
Name	Address	ID/FEI	Business Operations
Elan Cosmetic Co.,ltd		688204926	manufacture(82450-010)