MISSHA M PRISM BRIGHT ON AUTO NO.2 SPF35 PA PLUS PLUS PLUS- titanium dioxide, octinoxate, zinc oxide powder 
ABLE C&C CO., LTD.

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 INGREDIENT

ACTIVE INGREDIENTS: Titanium Dioxide 8.54%, Ethylhexyl Methoxycinnamate 6%, Zinc Oxide 2.94%

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

PURPOSE: This combination of Cosmetic / OTC Drug can be used as a sunscreen and as a cosmetic to cover your blemishes / scar and to tone up your skin care.

WARNINGS

WARNING:
For external use only.
Do not swallow.
Keep out of reach of children.
Avoid contact with eyes.
Do not use on exposed wounds or if you are allergic to any ingredients of this product.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE AND ADMINISTRATION:
Take appropriate amount according to your skin condition and apply as you desire.
Remove it before sleeping.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

MISSHA M PRISM BRIGHT ON AUTO  NO.2 SPF35 PA PLUS PLUS PLUS
titanium dioxide, octinoxate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13733-017
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.81 g  in 9.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.57 g  in 9.5 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.28 g  in 9.5 g
Inactive Ingredients
Ingredient NameStrength
Talc (UNII: 7SEV7J4R1U)  
Mica (UNII: V8A1AW0880)  
Magnesium Myristate (UNII: Z1917F0578)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13733-017-019.5 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/2012
Labeler - ABLE C&C CO., LTD. (689540284)
Registrant - ABLE C&C CO., LTD. (689540284)
Establishment
NameAddressID/FEIBusiness Operations
ABLE C&C CO., LTD.689540284manufacture(13733-017)

Revised: 10/2012
Document Id: 7d4f3728-9ac2-4b6c-9d24-5f22bb430dc9
Set id: 1bcd928e-b137-4551-b53f-ac0bb798f427
Version: 1
Effective Time: 20121029
 
ABLE C&C CO., LTD.