Label: ALBA BOTANICA SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate lotion

  • NDC Code(s): 61995-2029-1, 61995-2029-2, 61995-2029-3
  • Packager: The Hain Celestial Group, Inc
  • 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 February 20, 2023

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  • ACTIVE INGREDIENT

    Avobenzone 3%

    Homosalate 10%

    Octocrylene 10%

    Octisalate 5%

  • DOSAGE & ADMINISTRATION

    ● Apply liberally 15 minutes before sun exposure ● Reapply: ● after 80 minutes of swimming or sweating ● immediately after towel drying ● at least every 2 hours ● Children under 6 months of age: ask a doctor

    ● Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    ● limit time in the sun, especially from 10 am - 2 pm

    ● wear long-sleeved shirts, pants, hats, and sunglasses

  • PURPOSE

    Sunscreen

  • WARNINGS

    For external use only. Do not use on broken or damaged skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if skin rash occurs. If swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INACTIVE INGREDIENT

    Water (Aqua), Butyloctyl Salicylate, Dodecane, VP/Hexadecene Copolymer, Polyglyceryl-10 Pentastearate, Glycerin, Cetyl Alcohol, Glyceryl Stearate SE, Glyceryl Oleate Citrate, Behenyl Alcohol, Phenoxyethanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Glycine Soja (Soybean) Oil, Aloe Barbadensis Leaf Juice (1), Tocopheryl Acetate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Citric Acid, Decane, Dimethylhydroxy Furanone, Nonanal, Nonane, Potassium Hydroxide, Sodium Phytate, Sodium Stearoyl Lactylate, Solanum Tuberosum (Potato) Starch, Sorbitan Olivate, Terpinel Acetate, Vanillin, Alcohol (1), Ethylhexylglycerin, Potassium Sorbate, Sodium Benzoate, Limonene

    (1) Certified Organic Ingredient

  • INDICATIONS & USAGE

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ALBA BOTANICA SPF 50 SUNSCREEN 
    avobenzone, homosalate, octocrylene, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-2029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VANILLIN (UNII: CHI530446X)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)  
    CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    .ALPHA.-TERPINYL ACETATE, (+)- (UNII: T3M2S9HES8)  
    DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    C9-11 ALKANE/CYCLOALKANE (UNII: 3EZ541F5MW)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    NONANAL (UNII: 2L2WBY9K6T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61995-2029-159 g in 1 TUBE; Type 0: Not a Combination Product08/19/2019
    2NDC:61995-2029-289 g in 1 TUBE; Type 0: Not a Combination Product08/19/2019
    3NDC:61995-2029-3113 g in 1 TUBE; Type 0: Not a Combination Product08/19/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/19/2019
    Labeler - The Hain Celestial Group, Inc (117115556)
    Registrant - The Hain Celestial Group, Inc (014334364)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Hain Celestial Group, Inc081512382manufacture(61995-2029)
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