Label: AVALON ORGANICS LAVENDER LUMINOSITY MOISTURE PLUS SPF15- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 11, 2012

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  • ACTIVE INGREDIENT

    Titanium Dioxide  2.0%

    Zinc Oxide  7.5%


  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburns
    • If used as described with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by sun exposure.
  • WARNINGS

    For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes.Rinse with water to remove. Stop use and ask a doctor if skin rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Apply liberally after cleansing and toning at 15 minutes before sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease risk, regularly use a sunscreen  with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in the sun, especially from 10am to 2pm and wear long-sleeved shirts, pants, hats and sunglasses.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice (1), Aqua (Water), Helianthus Annuus (Sunflower) Seed Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Glyceryl Stearate, Cetyl Alcohol, Glycerin, Polyglycerol-10 Laurate, Cetearyl Olivate, Magnesium Aluminum Silicate, Sorbitan Olivate, Borage Officinalis Seed Oil (1), Citrus Aurantifolia (Lime) Oil, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Linum Usitatissimum (Linseed) Oil (1), Rosa Canina Fruit Oil (1), Arnica Montana Flower  Extract (1), Calendula Officinalis Flower Extract (1), Camellia Sinenensis Leaf Extract (1), Chamomilla Recutita (Matricaria ) Flower Extract (1), Curcuma Longa (Tumeric) Root Extract (1), Laminaria Digita Extract (1), Lavandula Angustifolia (Lavender) Flower Extract (1), Saccharomyces/Xylinum/Black Tea Ferment, Ascorbic Acid, Tocopheryl Acetate, Alcohol (1), Benzyl Alcohol, Potassium Sorbate, Sodium Benzoate, Citral, Coumarin, Geraniol, Limonene, Linalool.


    (1) Certified Organic Ingredients

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of bottle front label     image of bottle back label

  • INGREDIENTS AND APPEARANCE
    AVALON ORGANICS LAVENDER LUMINOSITY MOISTURE PLUS SPF15 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-1320
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    BORAGE OIL (UNII: F8XAG1755S)  
    LIME OIL (UNII: UZH29XGA8G)  
    LEMON OIL (UNII: I9GRO824LL)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    TURMERIC (UNII: 856YO1Z64F)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    TEA LEAF (UNII: GH42T47V24)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRAL (UNII: T7EU0O9VPP)  
    COUMARIN (UNII: A4VZ22K1WT)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-1320-7198 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/18/2011
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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