Label: AV3712501 MINERAL SUNSCREEN SPF 18- titanium dioxide cream

  • Category: HUMAN PRESCRIPTION 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 March 23, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    Titanium Dioxide 7.0%

  • INDICATIONS & USAGE

                    USAGE

    • Helps prevent sunburn
    • Apply liberally at least 20 minutes prior to sun exposure
    • Reapply as needed
    • For children under the age of 6 months please contact physician before use
  • WARNINGS AND PRECAUTIONS

    WARNINGS and PRECAUTIONS

    For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse  throughly with water to remove.

    Stop use and consult a physician if rash or irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

  • QUESTIONS

    QUESTIONS?

    1-800-227-5120 or www.AvalonOrganics.com

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    AV3712501 MINERAL SUNSCREEN SPF 18 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:61995-1125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1125-399 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2006
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture