Label: AHAVA PROTECTING MOISTURIZING SPF50- avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion

  • NDC Code(s): 60289-300-24
  • Packager: AHAVA Dead Sea Laboratories Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone (2.998%)sunscreens
    Ensolizole (2%)sunscreens
    Homosalate (10%)sunscreens
    Octisalate (5%)sunscreens
    Octocrylene (10%)sunscreens
  • Uses

    • helps prevent sunburn
  • Warnings

    For External Use Only

    When using this product keep out of eyes. Rinse with water to remove

    Stop use and consult a doctor if rash or irritation develops and lasts

    Do not use on damaged or broken skin

    Keep out of reach of children. If swallowed, get medical attention or contact a Poison Control Center right away

  • Directions

    • apply liberally and evenly to clean face 15 minutes before sun exposure
    • apply daily for a clearer, brighter complexion
    • 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 a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • Inactive ingredients

    Aqua (Mineral Spring Water), Carthamus Tinctorius (Safflower) Oleosomes, Glycerin, C15-19 Alkane, Propanediol (Corn derived), Tapioca Starch, Coco-Caprylate/Caprate, Cellulose Acetate, PEG-100 Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, PEG-40 Stearate, Dimethyl Capramide, Cetearyl Alcohol, Phenoxyethanol, Aminomethyl Propanol, Hydrogenated Palm Glycerides, Erythritol, Parfum (Fragrance), Disodium Cetearyl Sulfosuccinate, Gluconolactone, Chlorphenesin, Sodium Citrate, Xanthan Gum, Sodium Hydroxide, Sodium Benzoate, Caprylyl Glycol, Didecyldimonium Chloride, Potassium Sorbate, Homarine HCl, Aloe Barbadensis (Aloe-Vera) Leaf Juice, Allantoin, Bacillus Ferment, Maris Aqua (Dead Sea Water/Osmoter).

  • SPL UNCLASSIFIED SECTION

    Manufactured by AHAVA Dead Sea Laboratories,
    Dead Sea, Israel, 8698000

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    AHAVA

    Protecting
    Moisturizing
    Lotion

    Broad Spectrum
    SPF 50
    PA ++++

    HYDRATE

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    AHAVA PROTECTING MOISTURIZING SPF50 
    avobenzone, ensulizole, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60289-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.02998 g  in 1 mL
    Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole0.02 g  in 1 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.1 g  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
    Glycerin (UNII: PDC6A3C0OX)  
    C15-19 Alkane (UNII: CI87N1IM01)  
    Starch, Tapioca (UNII: 24SC3U704I)  
    Cocoyl Caprylocaprate (UNII: 8D9H4QU99H)  
    Cellulose Acetate (UNII: 3J2P07GVB6)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    PEG-40 Stearate (UNII: ECU18C66Q7)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
    Erythritol (UNII: RA96B954X6)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Didecyldimonium Chloride (UNII: JXN40O9Y9B)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Homarine Hydrochloride (UNII: 8866LNG61N)  
    Aloe (UNII: V5VD430YW9)  
    Allantoin (UNII: 344S277G0Z)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60289-300-241 in 1 CARTON06/06/2022
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02006/06/2022
    Labeler - AHAVA Dead Sea Laboratories Ltd (600056907)
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