Label: SPF 15 BRIGHTENING MOISTURIZER- 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, Cetearyl Alcohol, Stearic Acid, Chondrus Crispus Extract, Glyceryl Stearate, Cocos Nucifera (Coconut) Oil1, Thymus Vulgaris (Thyme) Extract1, Linum Usitatissimum (Flax) Seed Oil, Rosemary Officinalis (Rosemary) Leaf Oil1, Butyrospermum Parkii (Shea Butter)1, Ginkgo Biloba Leaf Extract, Rosa Canina (Rosehip) Oil1, Chamomilla Recutita (Matricaria) Flower Extract, Olea Europaea (Olive) Leaf Extract, Cucumis Sativus (Cucumber) Fruit Extract, Borago Officinalis (Borage) Seed Oil, Ascorbic Acid (Vitamin C), Calendula Officinalis Flower Extract1, Methylcellulose, Pentapeptide, Camellia Sinensis Leaf Extract, Allantoin, Cedrus Atlantica (Cedarwood) Bark Oil, Pelargonium Graveolens (Geranium) Flower Oil, Citrus Aurantium Dulcis (Orange) Fruit Oil, Panthenol (Vitamin B5), Hydrolyzed Jojoba Esters, Sodium Hyaluronate, Tocopherol (Vitamin E), Ethylhexylglycerin, Phenethyl Alcohol.
    May Contain: Mica, 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 - 96 g Tube Carton

    MINERAL FUSION
    minerals on a mission

    SPF 15 brightening
    moisturizer
    with restoring vitamin c
    BROAD SPECTRUM

    softly illuminates and
    restores radiance

    SPF and peptide
    age-defense

    all skin types

    MOISTURIZE
    HYPO-ALLERGENIC. 100% VEGAN.

    Net Wt 3.4 oz / 96 g e

    Principal Display Panel - 96 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SPF 15 BRIGHTENING MOISTURIZER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55789-2905
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10.8 g  in 96 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 67.2 g  in 96 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    THYME (UNII: CW657OBU4N)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GINKGO (UNII: 19FUJ2C58T)  
    ROSA CANINA FLOWER OIL (UNII: DUY7M48I1T)  
    CHAMOMILE (UNII: FGL3685T2X)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    CUCUMBER (UNII: YY7C30VXJT)  
    BORAGE OIL (UNII: F8XAG1755S)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    METHYLCELLULOSE (400 MPA.S) (UNII: O0GN6F9B2Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    ORANGE (UNII: 5EVU04N5QU)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55789-2905-11 in 1 CARTON
    196 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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