Label: MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS- titanium dioxide, octinoxate, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 13733-017-01 - Packager: ABLE C&C 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 October 29, 2012
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, Mica, Nylon-12, Silica, Methyl Methacrylate Crosspolymer, Magnesium Myristate, Diisostearyl Malate, Phenyl Trimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Synthetic Beeswax, Pearl Powder, Plukenetia Volubilis Seed Oil, Lilium Candidum Flower Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Rose Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Freesia Refracta Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Triethylhexanoin, Magnesium Stearate, Triethoxycaprylylsilane, Dimethicone, Methicone, Ethylhexylglycerin, Glyceryl Caprylate, Stearic Acid, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Diphenyl Dimethicone/Vinyl Diphenyl Dimethicone/Silsesquioxane Crosspolymer, Phytosterols, Sodium Hyaluronate, Water, Butylene Glycol, Cetearyl Alcohol, Fragrance(Parfum), Iron Oxides - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS AND USAGE
INDICATION AND USAGE:
Step 1. Take an appropriate amount of powder onto vibrating puff and dab it on forehead, cheek and chin.
Step 2. Turn on the vibrating puff and spread the powder evenly on face.
Step 3. Turn off the vibrating puff to stop.- How to replace the puff
Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.
Step 2. Place the new puff in the casing.
Step 3. Press down on the puff to fix and arrange the edges.- How to replace the battery
Step 1. Hold the body of vibrating puff and slowly pull out the end to separate.
Step 2. Twist the body of vibrating puff to separate. (Do not twist the vibrator inside to avoid damage)
Step 3. Replace Lithium battery. - DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS
titanium dioxide, octinoxate, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13733-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 0.81 g in 9.5 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.57 g in 9.5 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.28 g in 9.5 g Inactive Ingredients Ingredient Name Strength Talc (UNII: 7SEV7J4R1U) Mica (UNII: V8A1AW0880) Magnesium Myristate (UNII: Z1917F0578) Dimethicone (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13733-017-01 9.5 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/01/2012 Labeler - ABLE C&C CO., LTD. (689540284) Registrant - ABLE C&C CO., LTD. (689540284) Establishment Name Address ID/FEI Business Operations ABLE C&C CO., LTD. 689540284 manufacture(13733-017)
