Label: SUNBRELLAS MINERAL SUNBLOCK SPF 30- zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 10, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Zinc Oxide  14.5.0%

    Titanium Dioxide  2.0%


  • INDICATIONS & USAGE

                   USES

    • Helps prevent sunburns
    • Higher SPF gives more sunburn protection
    • Moderate sun protection product
    • apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure
    • Reapply as needed after towel drying, swimming or sweating
    • Children after 6 months, ask doctor
  • 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 Poison Center right away.
  • USER SAFETY WARNINGS

    OTHER INFORMATION

    Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer and other harmful effects of the sun.
  • QUESTIONS

    QUESTIONS?

    1-877-JASON-01

    www.jason-natural.com

    The Hain Celestial Group, Inc.

    Melville, NY 11747

    Made in U.S.A.
  • PRINCIPAL DISPLAY PANEL

    image of tube label

  • INGREDIENTS AND APPEARANCE
    SUNBRELLAS MINERAL SUNBLOCK SPF 30 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide14.5 g  in 100 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide2.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-0210-4113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/03/2009
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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