Label: CATRIN DIAMOND MINERAL FOUNDATION- titanium dioxide, zinc oxide powder

  • 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 January 13, 2015

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  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 15.4%, Zinc Oxide 13%

  • INACTIVE INGREDIENT

    Inactive ingredients: Mica, Bismuth Oxychloride, CI 77492, CI 77491, CI 77499, Quartz, Sapphire Powder, Diamond powder

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only. When using this product: Keep out of eyes, Rinse with water to remove. Stop use and ask a doctor if: Rash or irritation develops and lasts, Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications and usage: Helps prevent sunburn, Higher SPF gives moresunburn protection.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: Apply evenly before sun exposure as needed.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CATRIN DIAMOND MINERAL FOUNDATION 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69058-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.38 g  in 9 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.17 g  in 9 g
    Inactive Ingredients
    Ingredient NameStrength
    Mica (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69058-010-019 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2014
    Labeler - Nature&Bio Co., Ltd. (690332858)
    Registrant - Nature&Bio Co., Ltd. (690332858)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nature&Bio Co., Ltd.690332858manufacture(69058-010)
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