Label: ALBA HAWAIIANDRY SUNSCREEN SPF15- homosalate, octisalate, octocrylene, avobenzone oil

  • 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 January 22, 2014

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  • WARNINGS AND PRECAUTIONS

    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. 

  • Drug Facts

    Homosalate   10%

    Ethylhexyl Salicylate   5.0%

    Octocrylene  3.0%

    Butyl Methoxydibenzoylmethane  2.0%

  • PURPOSE

    Purpose: Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

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

  • OTHER SAFETY INFORMATION

    Sun Protection Measures: Spending time

  • INACTIVE INGREDIENT

    Ethylhexyl Palmitate, Carthamus Tinctorius (Safflower) Seed Oil (1), Cocos Nucifera (Coconut) Oil (1), Butyrospermum Parkii (Shea) Butter, Daucus Carota Sativa (Carrot) Seed Oil, Tocopherol, Tocopherol Acetate, Phenixyethanol, Fragrance.

    (1) Certified Organic Ingredient

  • PRINCIPAL DISPLAY PANEL

    bottle label

  • INGREDIENTS AND APPEARANCE
    ALBA HAWAIIANDRY SUNSCREEN SPF15 
    homosalate, octisalate, octocrylene, avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.0 g  in 133 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 133 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.0 g  in 133 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.0 g  in 133 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2102-4133 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/14/2014
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture(61995-2102)
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