Label: ALBA LIP CARE SUNBLOCK SPF 25- octocrylene, ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicilate 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 July 26, 2010

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    Octocrylene      10.0%

    Ethylhexyl Methoxycinnamate    7.5%

    Zinc Oxide  3.9%

    Ethylhexyl Salicilate    1.0%


  • 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
  • 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.
  • 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.
  • PRINCIPAL DISPLAY PANEL

    image of carton

  • INGREDIENTS AND APPEARANCE
    ALBA LIP CARE SUNBLOCK SPF 25 
    octocrylene, ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicilate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2394
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene10 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37) Zinc Oxide3.9 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate1.0 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2394-11 in 1 CARTON
    14.2 g in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/27/2009
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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