Label: ALBA BOTANICA NATURAL VERY EMOLLIENT DAILY SHADE SPF15- homosalate, ethylhexyl salicylate, octocrylene 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 April 26, 2012

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  • ACTIVE INGREDIENT

    Homosalate  7.5%

    Ethylhexyl Salicylate  5.0

    Octocrylene 3.0%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburns
  • 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 over entire body after bath or shower, at least 15 minutes before sun exposure and every 2 hours during sun exposure. Children under 6 months ask a doctor.

  • INACTIVE INGREDIENT

    Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate SE, Carthamus Tinctorius (Safflower) Oil, Cetearyl Alcohol,  Hydrogenated Palm Kernel Oil, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Vitus Vinifera (Grape) Seed Oil, Aloe Barbadensis Leaf Juice (1), Camellia Sinenensis Leaf Extract (1), Chamomilla Recutita (Matricaria ) Flower Extract (1), Cucumus Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia Extract, Lavandula Angustifolia (Lavender) Extract (1), Allantoin, Ascorbic Acid, Glycolic Acid, Lactic Acid, Lecithin, Panthenol, Polysorbate 60, Potassium Hydroxide, Tocopheryl Acetate, Alcohol (1), Xanthan Gum, Benzoic Acid, Dehydroacetic Acid, Phenoxyethanol, Fragrance (Parfum)


    (1) Certified Organic Ingredients

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA NATURAL VERY EMOLLIENT DAILY SHADE SPF15 
    homosalate, ethylhexyl salicylate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2371
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2371-2340 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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