Label: SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK- dimethicone powder
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Contains inactivated NDC Code(s)
NDC Code(s): 71322-050-01, 71322-050-02 - Packager: Sonatural Global Co.,Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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: Talc, Silica, Methyl Methacrylate Crosspolymer, Caprylic/Capric Triglyceride, Boron Nitride, Phenyl Trimethicone, Triethoxycaprylylsilane, Magnesium Stearate, Diisostearyl Malate, Caprylyl Glycol, Ethylhexylglycerin, CI 77491, Mica (CI 77019), 1,2-Hexanediol, Titanium Dioxide (CI 77891), CI 77499, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Red 7, Methicone, Tin Oxide, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil
- 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
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SONATURAL POW DER4ROOM MAKEUP HOLDING FINISH POW DER FIXER BRIGHT PINK
dimethicone powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71322-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 0.12 g in 6 g Inactive Ingredients Ingredient Name Strength Talc (UNII: 7SEV7J4R1U) Phenyl Trimethicone (UNII: DR0K5NOJ4R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71322-050-02 1 in 1 CARTON 03/02/2017 1 NDC:71322-050-01 6 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 final part347 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(71322-050) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(71322-050)
