Label: KATHARI SUN SHIELD DROPS NATURAL SPF 50- titanium dioxide, zinc oxide oil
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Contains inactivated NDC Code(s)
NDC Code(s): 82710-000-01 - Packager: Kathari LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 May 10, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
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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:
- Directions:
- Warnings
- Package Labeling:
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INGREDIENTS AND APPEARANCE
KATHARI SUN SHIELD DROPS NATURAL SPF 50
titanium dioxide, zinc oxide oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82710-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 72 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 95 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82710-000-01 28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 04/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/04/2022 Labeler - Kathari LLC (077635237)