Label: KID SAFE SCREEN- zinc oxide cream

  • 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 December 21, 2017

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT:

    20% non-nano zinc oxide

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:

    green and white tea, fractioned coconut oil, avocado oil, arabinogalactin, vitamin E, mango butter, potassium sorbate, vegetable glycerin, xanthan gum, allantoin, Cosmocil CQ, glycine (soya) lecithin, rosemary oleoresin, ylang ylang essential oil, iron oxides

    green and white tea for anti-oxidant support

    Cosmocil CQ, a paraben-free anti-microbial agent


  • DESCRIPTION

    DIRECTIONS:

    Shake well.
    Provides instant protection upon application.
    Reapply every two hours and after swimming, perspiring, or towel drying.
    Kid Safe Screen is so safe and gentle, it can be used around the eyes.

    If irritation develops discontinue use.

    For children under 6 months, consult a physician.

    OTHER INFORMATION:

    ENVIRONMENTAL FACTS

    Bottle Widely Recyclable I Content Biodegradable

    10% of profits donated to global organizations dedicated to keeping children safe around the world.

    DISTRIBUTOR:

    Marie Veronique Organics
    Berkeley CA 94710

    Made in USA

    mvorganics.com

  • PRINCIPAL DISPLAY PANEL

    KID SAFE SCREEN

    SPF 25+ provides broad-spectrum UVA/UVB protection and is made with 16 intelligent ingredients. No nanoparticle. No harmful chemicals. That's because what goes on your skin, goes into your body.

    Marie Veronique
    ORGANICS
    Intelligent Ingredients

    2.7oz / 80ml

    MVO001_V1_image

  • INGREDIENTS AND APPEARANCE
    KID SAFE SCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCINE (UNII: TE7660XO1C)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4054-180 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2010
    Labeler - Allure Labs, Inc. (926831603)
    Registrant - Allure Labs, Inc. (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc.926831603manufacture(62742-4054)
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