Label: BRONZING MINERAL BEAUTY BALM SPF 15- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 28, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Titanium Dioxide 6%
    Zinc Oxide 4%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    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.

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

  • Inactive Ingredients

    Aqua, Polysorbate 20, Cetyl Alcohol, Stearyl Alcohol, Tocopherol, Dimethicone, Emulsifying Wax, Caprylic/Capric Triglyceride, Glycerin, Hydroxyethylcellulose, Sodium Hydroxide, Alcohol, Coco-caprylate/Caprate, Sodium Alginate, Xanthan Gum, Butyrospermum Parkii (Shea Butter), Aloe Barbadensis (Aloe) Leaf Juice, Palmitoyl Tripeptide-5, Lavandula Angustifolia (Lavender) Flower Extract, Roman Anthemis Nobilis (Chamomile) Flower Extract, Rosa Canina (Rosehip) Oil*, Ginkgo Biloba Extract, Romarinus Officinalis (Rosemary) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Punica Granatum (Pomegranate) Seed Oil, Ascorbic Acid. May Contain: Mica, Red Iron Oxide, Yellow Iron Oxide, Black Iron Oxide.

  • 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 Carton

    bronzing
    mineral beauty balm
    broad spectrum SPF 15

    BRONZE FINISH
    sunkissed glow for all skin tones

    MINERAL FUSION®
    minerals on a mission®

    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 Carton
  • INGREDIENTS AND APPEARANCE
    BRONZING MINERAL BEAUTY BALM SPF 15 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2403
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 g  in 60 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 42 mL  in 60 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALCOHOL (UNII: 3K9958V90M)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    GINKGO (UNII: 19FUJ2C58T)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    THYME (UNII: CW657OBU4N)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-2403-11 in 1 CARTON
    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 FINALpart35208/01/2014
    Labeler - Mineral Fusion Natural Brands (831770032)
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