Label: MINERAL SPF 40 MOISTURIZER- zinc oxide and titanium dioxide lotion

  • 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

    Active IngredientsPurpose
    Titanium Dioxide 7.5%Sunscreen
    Zinc Oxide 5.0%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 to clean skin 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

    Mineral Water (Aqua), Aloe Barbadensis (Aloe Vera) Leaf Juice1 Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glyceryl Stearate, Cetyl Dimethicone, Vegetable Glycerin, Hexyl Laurate, Polyglyceryl-4 Isostearate, Cetyl Alcohol, Myristyl Myristate, Simmondsia Chinensis (Jojoba) Seed Oil1 Butyrospermum Parkii (Shea) Butter1, Panthenol, Malachite Extract, Smithsonite Extract, Rhodochrosite Extract, Hematite Extract, Palmitoyl Pentapeptide-3, Cucumis Sativus (Cucumber) Fruit Extract1, Tocopherol Acetate, Allantoin, Soy Lecithin, Camellia Sinensis (Green Tea) Leaf Extract1, Sodium PCA, Hyaluronic Acid, Chamomilla Recutita (Matricaria) Flower Extract1, Rosmarinus Officinalis (Rosemary) Leaf Oil, Calendula Officinalis Flower Extract1, Cedrus Atlantica (Cedarwood) Bark Oil, Ginkgo Biloba Leaf Extract1, Alaria Esculenta (Sea Kelp) Extract, Pelargonium Graveolens (Geranium) Flower Oil, Magnesium Aluminum Silicate, Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Natural Fragrance.

    1
    Certified Organic
  • Questions

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

  • SPL UNCLASSIFIED SECTION

    Dist. by Mineral Fusion
    Petaluma, CA 94954 USA

  • PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

    Mineral SPF 40
    Moisturizer

    Nourishing Hydration
    with Shea Butter
    Broad Spectrum

    MINERAL
    FUSION®

    Making
    Beauty
    Healthy®

    Net Wt 3.4 oz e 96 g

    PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL SPF 40 MOISTURIZER 
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-3109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-3109-21 in 1 CARTON09/17/2019
    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 FINALpart35212/10/2012
    Labeler - Mineral Fusion brands (831770032)
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