Label: ALBA BOTANICA NATURAL VERY EMOLLIENT SUNSCREEN KIDS SPF40- homosalate, ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane spray

  • 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 3, 2012

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  • ACTIVE INGREDIENT

    Homosalate    12.0%

    Ethylhexyl Methoxycinnamate   7.5%

    Octocrylene    7.0%

    Ethylhexyl Salicylate  5.0%

    Butyl Methoxybenzoylmethane  3.0%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburn
  • WARNINGS

    For external use only. Do not use on damaged or broken skin. 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 15 minutes before sun exposure. Reapply after 80 min of swimming or sweating,after towel drying and at lease every two hrs. Children under 6 mos ask a doctor.
    Skin protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease a risk,regularly use a Sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially 10am- 2pm, wear long- sleeved shirts,pants, hats and sunglasses.
  • INACTIVE INGREDIENT

    Aqua (Water), Aloe Barbadensis Leaf Juice (1), Glycerin, VP/Hexadecene Copolymer, Sodium Stearoyl Glutamate, Calendula Officinalis Flower Extract (1), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract (1), Gingko Biloba Root Extract,Citrus Aurantium Dulcis (Orangr) Peel Oil, Glycine Soja (Soybean) Oil,Cetyl Alcohol, Citric Acid, Glyceryl Stearate SE, Potassium Cetyl Phosphate, Sodium Chloride, Tocopheryl Acetate, Xanthan Gum,  Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, A-Terpinyl Acetate, Dimethylhydroxy Furanone, Nonanal, Vanillin, Limonene, Linalool.

    (1) Certified Organic Ingredient

  • QUESTIONS

    888-659-7730, www.AlbaBotanica.com

  • PRINCIPAL DISPLAY PANEL

    image of front label        image of back label   
        

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA NATURAL VERY EMOLLIENT SUNSCREEN KIDS SPF40 
    homosalate, ethylhexyl methoxycinnamate, octocrylene, ethylhexyl salicylate, butyl methoxydibenzoylmethane spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2385
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE12 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    GINKGO (UNII: 19FUJ2C58T)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TERPINYL ACETATE (UNII: NIT9SZT3D7)  
    4-HYDROXY-2,5-DIMETHYLFURAN-2(3H)-ONE (UNII: 20PI8YZP7A)  
    NONANAL (UNII: 2L2WBY9K6T)  
    VANILLIN (UNII: CHI530446X)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2385-4113 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/29/2011
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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