Label: ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50)- homosalate, octinoxate, octisalate, zinc oxide liquid

  • NDC Code(s): 81746-183-00, 81746-183-01
  • Packager: ZITSTICKA, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts.

  • Active Ingredients

    Homosalate 7.50% Octinoxate 7.50% Octisalate 5.00% Zinc Oxide 3.00%


    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection
    • 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
  • 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:

    Rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding,

    ask a health professional before use

  • Directions:

    • Apply liberally 15 minutes before sun exposure • Children under 6 months of age: ask a doctor. • Reapply at least every 2 hours • Reapply as needed  • Use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: • Limit time in the sun, especially from 10 a.m. - 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.






  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Teat) Extract, Caprylic/Capric Triglyceride, Carbomer, Citric Acid, Citrullus Lantus (Watermelon) Extract, Ceramide NG, Cetearyl Alcohol, Cetearyl Glucoside, Cocamidopropyl Betaine, Colloidal Oatmeal, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ferulic Acid, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hyaluronic Acid, Hydrogenated Methyl Abietate, Hydropropyl Cyclodextrin, Leuconostoc/Radish Root Ferment Filtrate, Melaleuca Alternifolia (Tea Tree) Oil, Niacinamide, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Palmitoyl Tripeptide-38, Phenyl Trimethicone, Polysorbate-20, Terminalia Ferdinandiana (Kakadu Plum) Oil, Thymus Vulgaris (Thyme) Extract.

  • Other Information:

    Protect the product in this container from excessive heat and direct sun.

  • Questions?

    +1 (424) 274 4500

  • Package Labeling:81746-183-00

    Bottle

  • Package Labeling:81746-183-01

    Bottle2

  • INGREDIENTS AND APPEARANCE
    ZITSTICKA MEGASHADE SUNSCREEN SERUM (SPF-50) 
    homosalate, octinoxate, octisalate, zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81746-183
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE75 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATERMELON (UNII: 231473QB6R)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    OATMEAL (UNII: 8PI54V663Y)  
    CARROT (UNII: L56Z1JK48B)  
    DODECANE (UNII: 11A386X1QH)  
    FERULIC ACID (UNII: AVM951ZWST)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    THYME (UNII: CW657OBU4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81746-183-001 in 1 BOX04/10/2021
    150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:81746-183-011 in 1 BOX09/01/2021
    230 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/10/2021
    Labeler - ZITSTICKA, Inc (117778611)
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