Label: ALBA SUNBLOCK NATURAL LAVENDER SPF 45 - homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicilate, titanium dioxide cream

  • NDC Code(s): 61995-2393-4
  • Packager: The Hain Celestial Group, Inc.
  • 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 July 6, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Homosalate       10.0%

    Octocrylene      10.0%

    Ethylhexyl Methoxycinnamate    7.5%

    Ethylhexyl Salicilate    5.0%

    Titanium Dioxide    2.0% Close
  • INDICATIONS & USAGE

                                     USES

    •     Helps prevent sunburns
    •     Higher SPF gives more sunburn protection
    •     Apply liberally as needed 15 to 20 minutes before sun exposure
    •      Reapply as needed or after swimming, perspiring or towel drying
    •      Children under 6 months of age: ask doctor
    Close
  • 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. Close
  • QUESTIONS

    QUESTIONS?

    Call (888) 659-7730 or visit www.AlbaBotanica.com

    100% Vegetarian Ingredients

    No Animal Testing

    Alba Botanica

    The Hain Celestial Group, Inc.

    Melville, NY 11747

    Made in the U.S.A. Close
  • INGREDIENTS AND APPEARANCE
    ALBA SUNBLOCK NATURAL LAVENDER SPF 45 
    homosalate, octocrylene, ethylhexyl methoxycinnamate, ethylhexyl salicilate, titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61995-2393
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 10 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 10 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 7.5 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 5.0 g  in 100 g
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 2.0 g  in 100 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61995-2393-4 113 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 10/28/2009
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    Name Address ID/FEI Business Operations
    The Hain Celestial Group, Inc. 858894996 manufacture
    Close