Label: KATHARI SUN SHIELD DROPS NATURAL SPF 50- titanium dioxide, zinc oxide oil

  • Category: HUMAN OTC DRUG LABEL

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 May 10, 2022

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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 7.2%

    Zin Oxide (Non-Nano) 9.5%

    Purpose:

    sunscreen

  • Inactive Ingredients:

    Carthamus Tinctorius (Safflower) Seed Oil, Cocunut Alkanes (and) Coco-caprylate. Caprate, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Oil, Vitis Vinifera (Grape) Seed Oil, *CO Pongamia Glabra Seed Oil, Olea Europae (Olive) Fruit Oil, Argania Spinosa Kernal Oil, Steario Acid, Polyhydroxystearic Acid, Tocopheryl Acetate (Vitamin E), Alumina, Oryza Sativa (Rice) Bran Extract, Bisabolol, Helianthus Annuus (Sunflower) Extract, **Squalane, Rosmarinus Officinialis (Rosemary) Leaf Extract, Tocopherol

  • Uses:

    Provides high protection against sunburns

  • Directions:

    Shake before use, apply 4-6 drops to hands and massage thin layer over clean skin, final step in skincare routine. Allow 15 minutes of complete penetration before sun exposure. Reapply every 1-2 hours & after swimming or sweating.

  • Warnings

    when using this product

    Keep out of the eye area. Rinse with water to remove.

    Stop usage and ask a doctor 

    if rash or irritation develops. For external use only.

    Keep out of the reach of children.

  • Package Labeling:

    Label0Label02

  • INGREDIENTS AND APPEARANCE
    KATHARI SUN SHIELD DROPS NATURAL SPF 50 
    titanium dioxide, zinc oxide oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82710-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE72 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION95 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    RICE BRAN (UNII: R60QEP13IC)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    SQUALANE (UNII: GW89575KF9)  
    ROSEMARY (UNII: IJ67X351P9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82710-000-0128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product04/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/04/2022
    Labeler - Kathari LLC (077635237)
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