Label: ALBA BOTANICA NATURAL EVEN ADVANCED SEA MOSS MOISTURIZER SPF15- homosalate, octocrylene, ethylhexyl salicylate 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 18, 2012

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  • ACTIVE INGREDIENT

    Homosalate    7.5%

    Octocrylene    5.0%

    Ethylhexyl Salicylate  5.0%


  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    • Helps prevent sunburn
  • 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 daily to clean face and neck. Apply at least 15 minutes before and every 2 hours during sun exposure. Children under 6 months: ask a doctor.
    Skin protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer and early skin aging.
  • INACTIVE INGREDIENT

    Aqua (Water), Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate SE, Cetearyl Olivate, Sorbitan Olivate,   VP/Hexadecene Copolymer, Hydrogenated Palm Kernel Oil, Aloe Barbadensis Leaf Juice (1), Chondrus Crispus (Sarrageenan) Extract (1) (2), Camellia Sinensis Leaf Extract (1), Chamomilla Recuitita (Matricaria) Flower Extract (1), Laminaria Digitata  Extract, Macrocystis Purifera Extract, Spirulina Maxima Extract, Ulva Lactuca Extract (1), Cetyl Alcohol, Allantoin  Ascorbic Acid, Ascorbyl Glucoside, Carthamus Tinctorius (Safflower) Oleosomes, Diacetyl Boldine, Erythritol, Homarine HCl, Montmorillonite, Panthenol ,Sodium Stearoyl Glutamate, Ethylhexylglycerin, Gluconolactone, Tocopheryl Acetate, Xanthan Gum,  Alcohol (1), Benzyl Alcohol, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Benzyl Benzoate, Hexyl Cinnamal, Limonene, Linalool, Fragrance (Parfum).

    (1) Certified Organic Ingredient

    (2) Sea Moss Extract

  • QUESTIONS

    888-659-7730, www.AlbaBotanica.com

  • PRINCIPAL DISPLAY PANEL

    image of tube label       image of carton label
        

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA NATURAL EVEN ADVANCED SEA MOSS MOISTURIZER SPF15 
    homosalate, octocrylene, ethylhexyl salicylate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    DIACETYL BOLDINE (UNII: 37727Z7M0I)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    MONTMORILLONITE (UNII: A585MN1H2L)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2312-21 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/02/2011
    Labeler - The Hain Celestial Group, Inc. (858894996)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.858894996manufacture
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