Label: SONATURAL POW DER4ROOM FIXING IT FULL COVER NEUTRAL BEIGE- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71322-120-01, 71322-120-02 - Packager: Sonatural Global Co.,Ltd
- 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 March 23, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: Cyclopentasiloxane, Water, Methyl Methacrylate Crosspolymer, Butylene Glycol, CI 77492, Dicaprylyl Carbonate, Glycerin, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Beeswax, Cetearyl Alcohol, PEG-10 Dimethicone, Triethoxycaprylylsilane, CI 77491, Disteardimonium Hectorite, Tocopheryl Acetate, Sodium Chloride, Dimethicone/PEG-10/15 Crosspolymer, Portulaca Oleracea Extract, Aluminum Hydroxide, CI 77499, Phenoxyethanol, Triethyl Citrate, Caprylyl Glycol, Boron Nitride, Silica, Mica (CI 77019), 1,2-Hexanediol, Ethylhexylglycerin, Adenosine, Calendula Officinalis Flower Extract, Disodium EDTA, Propylene Glycol, Dipropylene Glycol, Rosa Canina Fruit Oil, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Sodium Citrate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol
- PURPOSE
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WARNINGS
Warnings: 1. If the following symptoms occur, discontinue use and consult a dermatologist: 1) Red spots, swelling, itchiness, or irritation upon use 2) If above symptoms occur when skin is in direct sunlight 2. Do not use on open wounds and on skin with eczema or dermatitis 3. Storage instructions: 1) Close lid tightly after each use 2) Keep out of reach of children 3) Store at room temperature away from direct sunlight
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SONATURAL POW DER4ROOM FIXING IT FULL COVER NEUTRAL BEIGE
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71322-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 9.04 g in 45 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.83 g in 45 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:71322-120-02 1 in 1 CARTON 03/02/2017 1 NDC:71322-120-01 45 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 03/02/2017 Labeler - Sonatural Global Co.,Ltd (694818511) Registrant - Sonatural Global Co.,Ltd (694818511) Establishment Name Address ID/FEI Business Operations Sonatural Global Co.,Ltd 694818511 relabel(71322-120) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71322-120)
