Label: METABOLIC BRIGHTENING BB CUSHION- titanium dioxide, zinc oxide, alpha bisabolol powder
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Contains inactivated NDC Code(s)
NDC Code(s): 82450-010-01, 82450-010-02 - Packager: rootsallo Qwell
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated December 30, 2021
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- ACTIVE INGREDIENTS
- PURPOSE
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
METABOLIC BRIGHTENING BB CUSHION
titanium dioxide, zinc oxide, alpha bisabolol powderProduct 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)