Label: ILLUMINATING MINERAL BEAUTY BALM WITH SPF 9- titanium dioxide cream

  • NDC Code(s): 55789-2401-1
  • Packager: Mineral Fusion Natural Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 17, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Titanium Dioxide 7.4%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
  • Warnings

    Skin Cancer/Skin Aging Alert

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging.

    • For external use only.

    • Do not use on damaged or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    Apply liberally 15 minutes before sun exposure.

    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Children under 6 months: Ask a doctor.
  • Inactive Ingredients

    Water (Aqua), Caprylic/Capric Triglyceride, Jojoba Esters, Mica, Vegetable Glycerin, Sorbitan Sesquioleate, Cetearyl Olivate, Sorbitan Olivate, Potassium Cetyl Phosphate, Dimethicone, Hydroxyethylcellulose, Citric Acid, Punica Granatum (Pomegranate) Extract, Tetrahexyldecyl Ascorbate (Vitamin C), Mineral-Peptide Blend (Magnesium Asparate, Zinc Gluconate, Copper Gluconate, and Palmitoyl Tripeptide-5), Camellia Sinensis (White Tea) Leaf Extract, Aloe Barbadensis Leaf Juice, Glycyrrhiza Glabra (Licorice) Extract, Lavandula Angustifolia (Lavender) Extract, Rosa Canina (Rose) Flower Extract, Olea Europaea (Olive) Leaf Extract, Potassium Sorbate, Sodium Dehydroacetate, Sodium Benzoate, Iron Oxides (CI 77491, CI 77492, CI 77499).

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or Comments?

    Call toll free 1-800-428-1668 Mon-Fri 8 AM-5 PM MST

  • PRINCIPAL DISPLAY PANEL - 60 ml Tube Label

    MINERAL FUSION®
    minerals on a mission®

    illuminating
    mineral beauty balm
    broad spectrum SPF 9

    LUMINOUS FINISH
    Ultra-sheer for all skin tones

    ALL-IN-ONE
    BB

    Makeup + moisturizer
    + age-defying treatment

    Hypo-allergenic, Fragrance free

    2.0 fl oz / 60 mL e

    Principal Display Panel - 60 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    ILLUMINATING MINERAL BEAUTY BALM WITH SPF 9 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE74 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MICA (UNII: V8A1AW0880)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-2401-11 in 1 CARTON04/01/2013
    160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/01/2013
    Labeler - Mineral Fusion Natural Brands LLC (831770032)
    Establishment
    NameAddressID/FEIBusiness Operations
    Columbia Cosmetics068267863MANUFACTURE(55789-2401)
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