avatara Kom Bu Cha The Simple Shield Balancing Oil-Free Moisturizer SPF 30 by Avatara Personal Care LLC DRUG FACTS

avatara Kom Bu Cha The Simple Shield Balancing Oil-Free Moisturizer SPF 30 by

Drug Labeling and Warnings

avatara Kom Bu Cha The Simple Shield Balancing Oil-Free Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Avatara Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AVATARA KOM BU CHA THE SIMPLE SHIELD BALANCING OIL-FREE MOISTURIZER SPF 30- sunscreen spf 30 lotion 
Avatara Personal Care 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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DRUG FACTS

Active Ingredients

Zinc Oxide 17%

Uses

helps prevent sunburn 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 docor if rash occurs
Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

apply generously 15 minutes before sun exposure
reapply at least every 2 hours
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
this risk, regularly use a sunscreen with a Broad Spectrum SPF
value 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
children under 6 months of age: Ask a doctor

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Glycerin, Butyloctyl Salicylate, Glyceryl Stearate, Polyhydrostearic Acid, PEG-100 Stearate, Butylene Glycol, Polyglyceryl-2 Stearate, Potassium Cetyl Phosphate, Cetyl Alcohol, Cetearyl Alcohol, Xanthan Gum, Pongamol, Saccharomyces/Xylinum/Black Tea Ferment, Ethylhexylglycerin, Xylitylglucoside, Anhydroxylitol, Tocopherol, Xylitol, Trisodium Ethylenediamine Disuccinate, Salicylic Acid, Ceramide NG, Chichorium Intybus (Chicory) Root Extract, Pentylene Glycol, Sodium Hyaluronate, Polysorbate 20

Other Information

protect the product in this container from excessive
heat and direct sun

Questions?

Call 1-888-883-5507

Principal Display Panel

83126-100-01

AVATARA KOM BU CHA THE SIMPLE SHIELD BALANCING OIL-FREE MOISTURIZER SPF 30 
sunscreen spf 30 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83126-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85)  
CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
GLYCINE (UNII: TE7660XO1C)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PEG-100 STEARATE (UNII: YD01N1999R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PONGAMOL (UNII: 8Y19QCY6I4)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
XYLITOL (UNII: VCQ006KQ1E)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
CERAMIDE NG (UNII: C04977SRJ5)  
CHICORY ROOT (UNII: 090CTY533N)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83126-100-011 in 1 CARTON11/26/2022
130 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/26/2022
Labeler - Avatara Personal Care LLC (032263874)

Revised: 11/2022