Label: SPF 16 BRIGHTENING- 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 21, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 10.5%

  • 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

    Mineral Water (Aqua), Vegetable Glycerin, Cocos Nucifera (Coconut) Oil1, Butyrospermum Parkii (Shea Butter) Fruit1, Thymus Vulgaris (Thyme) Extract1, Cetearyl Alcohol, Glyceryl Stearate, Chondrus Crispus Extract, Triisostearyl Citrate, Linum Usitatissimum (Flax) Seed Oil1, Rosemary Officinalis (Rosemary) Leaf Oil1, Persea Gratissima (Avocado) Butter, Ginkgo Biloba Leaf Extract1, Rosa Canina (Rosehip) Oil1, Chamomilla Recutita (Matricaria) Flower Extract1, Olea Europaea (Olive) Leaf Extract1, Cucumis Sativus (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Oil1, Borago Officinalis (Borage) Seed Oil1, Calendula Officinalis Flower Extract1, Pentapeptide, Methylcellulose, Camellia Sinensis Leaf Extract1, Cedrus Atlantica (Cedarwood) Bark Oil1, Pelargonium Graveolens (Geranium) Flower Oil, Panthenol (Vitamin B5), Ascorbic Acid (Vitamin C), Sodium Hyaluronate, Tocopherol (Vitamin E), Allantoin, Mica, Ethylhexylglycerin, Phenethyl Alcohol. May contain: Titanium Dioxide, Iron Oxides.

    1
    Certified Organic
  • Questions

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

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    MINERAL FUSION
    minerals on a mission

    SPF 16
    brightening
    eye cream
    with firming rosehip oil
    BROAD SPECTRUM

    brightens, plumps,
    and firms

    SPF and peptide
    age-defense

    all skin types

    TREAT

    HYPO-ALLERGENIC. 100% VEGAN.

    Net Wt 1.0 oz / 28 g e

    Principal Display Panel - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPF 16 BRIGHTENING 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.94 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 19.6 g  in 28 g
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    THYME (UNII: CW657OBU4N)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    TRIISOSTEARYL CITRATE (UNII: 50XT325OOH)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    AVOCADO SEED BUTTER (UNII: TSD0N1V8MB)  
    GINKGO (UNII: 19FUJ2C58T)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE OIL (UNII: F8XAG1755S)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALLANTOIN (UNII: 344S277G0Z)  
    MICA (UNII: V8A1AW0880)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-2901-11 in 1 CARTON
    128 g 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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