KATHARI SUN SHIELD DROPS NATURAL SPF 50- titanium dioxide, zinc oxide oil 
Kathari LLC

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.

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Kathari Sun Shield Drops Natural SPF 50

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

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)

Revised: 5/2022
Document Id: deac5e37-e1a2-5b4b-e053-2a95a90a9d5b
Set id: 288c830d-2366-4c85-962e-cef4cb8a85dd
Version: 1
Effective Time: 20220510
 
Kathari LLC