MILKY DRESS THE WHITE PLATINUM- dimethicone cream 
JR Cosmetic 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 Ingredient: Dimethicone 2.50%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Butylene Glycol, Glycerin, Arbutin, Sodium Hyaluronate, Hydrogenated Polyisobutene, Titanium Dioxide, Triticum Vulgare(Wheat) Germ Oil, Cetyl Ethylhexanoate, Arctostaphylos Uva Ursi Leaf Extract, Aloe Barbadensis Leaf Juice, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copoymer, Isohexadecan, Polysorbate 80, Morus Alba Bark Extract, Ginkgo Biloba Leaf Extract, Citrus Paradisi(Grapefruit)Fruit Extract, Vitis Vinifera(Grape)Skin Extract, Centella Asiatica Extract, Allantoin, Panthenol, Physalis Alkekengi Fruit Extract, Taraxacum Officinale(Dandelion) Leaf Extract, Viscum Album(Mistletoe)Extract, Rosa Damascena Flower Extract, Rhodiola Rosea Root Extract, Calendula Officinalis Flower Extract, Rosmarinus Officinalis(Rosemary) Extract,Caprylyl Glycol, Ethylhexylglycerin, Tropolone, Fragrance, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Hydrolyzed Pea Protein, Phytosterols, Adenosine, Alpha-Arbutin, Lecithin, Olea Europaea(Olive) Fruit Oil,
Squalane, Disodium EDTA, Butyrospermum Parkii(Shea) Butter, Ceramide 3

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:
1. In case of having following symptoms after using this, you're advised to stop using it immediately.
If you keep using it, the symptoms will get worse and need to consult a dermatologist.
1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of babies and children.

INDICATIONS & USAGE

Indication and usage:
1. Tighten the lid after using it.
2. Don't keep it in the place where the temperature is extremely hot or low and exposed to the direct sunlight.
3. After basic skin care, apply it on the face, hands, feet and desired area.

DOSAGE & ADMINISTRATION

Dosage & Administration
After basic skin care, apply the proper amount on the face, hands, feet and desired area and pat it lightly for full absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MILKY DRESS THE WHITE PLATINUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69199-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone1.62 mg  in 65 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69199-010-0165 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2014
Labeler - JR Cosmetic Co., Ltd (688415648)
Registrant - JR Cosmetic Co., Ltd (688415648)
Establishment
NameAddressID/FEIBusiness Operations
JR Cosmetic Co., Ltd688415648manufacture(69199-010)

Revised: 9/2014
Document Id: 5d8624e1-eec9-494e-8370-49ea8b8a1bdd
Set id: 214f8386-f0c2-47db-bb73-797a9d560390
Version: 1
Effective Time: 20140926
 
JR Cosmetic Co., Ltd