Label: ALBA EVEN ADVANCED SEA MOSS MOISTURIZER SPF15- homosalate, ethylhexyl salicylate, octocrylene, butyl methoxydibenzoylmethane lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 2, 2022

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  • ACTIVE INGREDIENT

    Active Ingredient

    Homosalate - 7.5%

    Octocrylene -3.0%

    Ethylhexyl Salicylate - 5.0%

    Butyl Methoxydibenzoylmethane - 2.0%

  • DOSAGE & ADMINISTRATION

    Apply liberally after cleansing and toning and 15 minutes before sun exposure. Reapply every 2 hours during sun exposure.

  • PURPOSE

    Sunscreen

  • 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 Poison Center right away.

  • INACTIVE INGREDIENT

    Water, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, VP/Hexadecene Copolymer, Caprylic/Capric Triglyceride, Hydrogenated Palm Cernel Oil, Aloe Barbadensis Leaf Juice(1), Camellia Sinensis Leaf Extract (1), Chamomilla Recutita (Matricaria) Flower Extract (1), Chondrus Crispus Extract (1), (2), Enteromorpha Compressa Extract, Laminaria Digitata Extract, Macrocystis Pyrifera Extract, Spirulina Maxima Extract, Ulva Lactuca Extract (1), Allantoin, Ascorbic Acid, Ascorbyl Glucoside, Caesalpinia Spinosa Gum, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Olivate, , Lecithin, Diacetyl Boldine, Erythritol, Homarine HCL, Panthenol, Gluconolactone, Sodium Chloride, Sodium Stearoyl Glutamate, Sorbitan Olivate, Tocopheryl Acetat, Xanthan Gum, Alcohol (1), Benzyl Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate.

    (1) Certified Organicf Ingredient, (2) Sea Moss Extract

  • INDICATIONS & USAGE

    Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by 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 sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.

  • PRINCIPAL DISPLAY PANEL

    carton labeltube label

  • INGREDIENTS AND APPEARANCE
    ALBA EVEN ADVANCED SEA MOSS MOISTURIZER SPF15 
    homosalate, ethylhexyl salicylate, octocrylene, butyl methoxydibenzoylmethane lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2031
    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 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    DIACETYL BOLDINE (UNII: 37727Z7M0I)  
    ERYTHRITOL (UNII: RA96B954X6)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2031-21 in 1 CARTON01/13/2014
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/13/2014
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-2031)