Label: TOURMANIUM BB SPF30 PA PLUS PLUS- zinc oxide cream 

  • Label RSS
  • NDC Code(s): 43275-140-01
  • Packager: NUGA MEDICAL CO., LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: Zinc Oxide 2.88%

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  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    Water, Butylene Glycol, Titanium Dioxide, Cetyl Ethylhexanoate, Talc, Octyldodecyl Myristate, Hydrogenated Polydecene, Jojoba Esters, Arbutin, Lecithin, Glyceryl Stearate, Sorbitan Sesquioleate, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Sorbitan Olivate, Dimethicone, Polysorbate 60, Aluminum Hydroxide, Stearic Acid, Polyacrylate-13, Propylene Glycol Stearate, Polyisobutene, Sorbitan Laurate, Dimethicone/Methicone Copolymer, Polysorbate 20, Glyceryl Polyacrylate, Propylene Glycol Laurate, Propylene Glycol, Acacia Seyal Gum Extract, Laminaria Japonica Extract, Saccharomyces Ferment Filtrate, Tourmaline, Gelatin, Bentonite, Sodium Citrate, Adenosine,Sorbitan Isostearate, Triethoxycaprylylsilane, Citric Acid, Xanthan gum, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol,Caprylyl Glycol, Ethylhexylglycerin, 1,2-Hexanediol

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  • PURPOSE

    PURPOSE: UVA/UVB protection

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  • WARNINGS

    WARNINGS:
    For external use only
    Do Not Use - On wounds or damaged skin
    When using this product:
    - do not use other than directed
    Stop use - If allergic reaction or irritation occurs

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  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

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  • INDICATIONS AND USAGE

    HOW TO USE
    After your daily skin care regimen, apply an even layer onto the face in upward and outward motions

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  • DOSAGE AND ADMINISTRATION

    HOW TO USE
    After your daily skin care regimen, apply an even layer onto the face in upward and outward motions

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  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    TOURMANIUM BB  SPF30 PA PLUS PLUS
    zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43275-140
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Zinc Oxide (ZINC OXIDE) ZINC OXIDE 1.15 g  in 40 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Butylene Glycol  
    Cetyl Ethylhexanoate  
    Talc  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43275-140-01 40 mL in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/01/2012
    Labeler - NUGA MEDICAL CO., LTD. (690034673)
    Registrant - NUGA MEDICAL CO., LTD. (690034673)
    Establishment
    Name Address ID/FEI Business Operations
    NUGA MEDICAL CO., LTD. 690034673 manufacture(43275-140)
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