Label: ROOTREE MOBITHERAPY UV SUN SHIELD- octinoxate, octisalate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 72441-070-01, 72441-070-02 - Packager: KTCS Corporation
- 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 December 31, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
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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
- WARNINGS
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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
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INGREDIENTS AND APPEARANCE
ROOTREE MOBITHERAPY UV SUN SHIELD
octinoxate, octisalate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72441-070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 4.2 g in 60 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 2.88 g in 60 g Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.24 g in 60 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72441-070-02 1 in 1 CARTON 07/01/2018 1 NDC:72441-070-01 60 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2018 Labeler - KTCS Corporation (688326214) Registrant - KTCS Corporation (688326214) Establishment Name Address ID/FEI Business Operations ATEC Co., Ltd. 689276681 manufacture(72441-070)
