Label: MINERAL SPF 30 SUN- titanium dioxide and zinc oxide stick

  • 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 21, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 5.0%
    Zinc Oxide 10.0%

  • 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
    • Reapply:
      • after 40 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours
    • 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 a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    Cocos Nucifera (Coconut) Oil1, Theobroma Cacao (Cocoa) Seed Butter1, Ricinus Communis (Castor) Seed Oil*, Linum Usitatissimum (Flax) Seed Oil1, Rosa Canina (Rosehip) Oil1, Ginkgo Biloba Leaf Extract1, Olea Europaea (Olive) Leaf Oil1, Rosemary Officinalis (Rosemary) Leaf Oil1, Butyrospermum Parkii (Shea Butter)1, Copernicia Cerifera (Carnauba) Wax1, Helianthus Annuus (Sunflower) Seed Oil1, Mineral Water, Borago Officinalis (Borage) Seed Oil1, Aloe Barbadenis Leaf Oil1, Calendula Officinalis Flower Oil1, Citrus Aurantium Dulcil (Orange) Peel Wax, Pentapeptide, Camellia Sinensis Leaf Oil1, Chamomilla Recutita (Matricaria) Flower Oil1, Cucumis Sativus (Cucumber) Fruit Extract, Cedrus Atlantica (Cedarwood) Bark Oil1, Silica, Pelargonium Graveolens (Geranium) Flower Oil, Vanilla Planifolia Fruit Oil, Panthenol (Vitamin B5), Allantoin, Tocopherol, (Vitamin E).

    1
    Certified Organic
  • Questions

    Call 1-800-428-1668 Mon-Fri 8 a.m. – 5 p.m. MST

  • PRINCIPAL DISPLAY PANEL - 9.5 g Cylinder Carton

    MINERAL FUSION
    minerals on a mission

    mineral SPF 30
    sun stick
    with peptide
    age-defense
    BROAD SPECTRUM

    mineral SPF
    spot treatment

    for sun-sensitive
    areas

    all skin types

    TREAT

    HYPO-ALLERGENIC. 100% VEGAN.

    Net Wt 0.33 oz / 9.5 g e

    PRINCIPAL DISPLAY PANEL - 9.5 g Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL SPF 30 SUN 
    titanium dioxide and zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.475 g  in 9.5 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.95 g  in 9.5 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L) 5.7 g  in 9.5 g
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    GINKGO (UNII: 19FUJ2C58T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSEMARY (UNII: IJ67X351P9)  
    SHEANUT OIL (UNII: O88E196QRF)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    WATER (UNII: 059QF0KO0R)  
    BORAGE OIL (UNII: F8XAG1755S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CITRUS SINENSIS FLOWER WAX (UNII: 8L3Z7JK2NU)  
    THYMOPENTIN (UNII: O3Y80ZF13F)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-2902-11 in 1 CARTON
    19.5 g in 1 CYLINDER; 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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