ROOTREE MOBITHERAPY UV SUN SHIELD- octinoxate, octisalate, titanium dioxide cream 
KTCS Corporation

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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ACTIVE INGREDIENTS

Ethylhexyl Methoxycinnamate 7.0%
Ethylhexyl Salicylate 4.80%
Titanium Dioxide 2.075%

INACTIVE INGREDIENTS

Water, Butylene Glycol, Glycerin, Dicaprylyl Carbonate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cyclopentasiloxane, Cyclohexasiloxane, Glyceryl Stearate, Stearic Acid, Potassium Cetyl Phosphate, Arachidyl Alcohol, Polysorbate 60, Dimethicone, PEG-100 Stearate, Polymethyl Methacrylate, Behenyl Alcohol, Dimethicone/ Vinyl Dimethicone Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylyl Glycol, Aluminum Hydroxide, Arachidyl Glucoside, Fragrance, Xanthan Gum, Arginine, Caprylhydroxamic Acid, Carbomer, Adenosine, Sesamum Indicum (Sesame) Sprout Extract, Glycine Soja (Soybean) Sprout Extract, Phaseolus Radiatus Sprout Extract, Lactobacillus Ferment Lysate, Dendropanax Morbifera Extract, Mentha Arvensis Leaf Extract, Brassica Napus Extract, Citrus Sudachi Fruit Juice, Dipotassium Glycyrrhizate, Disodium EDTA, Tocopheryl Acetate, Benzyl Alcohol, Centella Asiatica Extract

PURPOSE

Sunscreen

WARNINGS

- Cease use if problems arise after applying the product and consult a specialist on the symptoms

- Do not use on the wound

- Keep the product out of the reach of children and avoid storing in are as exposed to direct sunlight

DESCRIPTION

Uses:

It is a natural sun-cream product containing the ingredients extracted from Dendropanax Mobifera tree of Jeju. Its natural formulation protects skin from the UV ray A and B which cause skin-aging. It softly embraces skin with long lasting moisture and forwards rich natural moisturizing ingredients to your skin.

Directions:

At the last stage of basic skin care, apply the adequate amount on the areas such as face, neck, arms, legs and etc. which can be easily exposed to UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ROOTREE MOBITHERAPY UV SUN SHIELD 
octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72441-070
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate4.2 g  in 60 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.88 g  in 60 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.24 g  in 60 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72441-070-021 in 1 CARTON07/01/2018
1NDC:72441-070-0160 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2018
Labeler - KTCS Corporation (688326214)
Registrant - KTCS Corporation (688326214)
Establishment
NameAddressID/FEIBusiness Operations
ATEC Co., Ltd.689276681manufacture(72441-070)

Revised: 12/2020
Document Id: 112bf256-6d27-4ea6-a94d-bf49ad9353b1
Set id: c02c9385-21b8-4d80-bbdc-e1587aca2a51
Version: 2
Effective Time: 20201231
 
KTCS Corporation