Label: ALBA BOTANICA EVEN ADVANCED MOISTURIZER SPF15- avobenzone, octisalate, octocrylene lotion

  • NDC Code(s): 61995-3012-1
  • Packager: The Hain Celestial Group, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Avobenzone 3.0%

    Octisalate 5.0%

    Octocrylene 10.0%

  • DOSAGE & ADMINISTRATION

    For sunscreen use apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen when swimming or sweating.

  • 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 (Aqua), Coconut Alkanes, Glycerin, Sodium Stearoyl Glutamate, Citrus Aurantium Dulcis (Orange) Peel Oil, Shea Butter Ethyl Esters, Achillea Millefolium Flower Extract (1), Achillea Millefolium Flower/Leaf/Stem Extract, Alchemilla Vulgaris Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice (1), Caesalpinia Spinosa Gum, Cucumis Sativus (Cucumber) Fruit Extract, Enteromorpha Compressa Extract, Glycyrrhiza Glabra (Licorice) Root Extract (1), Laminaria Digitata Extract, Malva Sylvestris (Mallow) Flower Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Oryza Sativa (Rice) Starch, Primula Veris Extract, Ulva Lactuca Extract (1), Veronica Officinalis Flower/Leaf/Stem Extract, Ascorbic Acid, Ascorbyl Glucoside, Tocopheryl Acetate, Biosaccharide Gum-1, Caprylic/Capric Triglyceride, Citric Acid, Coco-Caprylate/Caprate, Cyamopsis Tetragonoloba (Guar) Gum (1), Diacetyl Boldine, Erythritol, Glyceryl Caprylate, Homarine HCl, Linalyl Acetate, Lysolecithin, Pullulan, Sclerotium Gum, Silica, Sodium Anisate, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Levulinate, Triethyl Citrate, Xanthan Gum, Alcohol, Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Amyl Cinnamal, Coumarin, Limonene, Linalool

    (1) Certified Organicf Ingredient

  • 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

    Label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA EVEN ADVANCED MOISTURIZER SPF15 
    avobenzone, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-3012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROLYZED ULVA COMPRESSA PROTEIN (ACID; 300-5000 MW) (UNII: Q04O53779D)  
    PRUNELLA VULGARIS FLOWER (UNII: AT1FD041EF)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    DIACETYL BOLDINE (UNII: 37727Z7M0I)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    CINNAMYLAMINE (UNII: 7360F8GA70)  
    COUMARIN (UNII: A4VZ22K1WT)  
    SODIUM LEVULINATE (UNII: VK44E1MQU8)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    ERYTHRITOL (UNII: RA96B954X6)  
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ULVA LACTUCA (UNII: PHR3P25W6Y)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    ALCOHOL (UNII: 3K9958V90M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
    MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    PRIMULA VERIS WHOLE (UNII: W6LFQ57E4M)  
    VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    CYAMOPSIS TETRAGONOLOBA WHOLE (UNII: K97Q182I2L)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N)  
    SODIUM ANISATE (UNII: F9WFJ28MV9)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-3012-11 in 1 CARTON08/17/2016
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/17/2016
    Labeler - The Hain Celestial Group, Inc. (117115556)
    Registrant - The Hain Celestial Group, Inc. (081512382)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc.081512382manufacture(61995-3012)