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

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated December 30, 2021

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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

  • INGREDIENTS AND APPEARANCE
    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)
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