3CE WHITE MILK CREA M- dimethicone cream 
Nanda 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 1.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Propanediol, Glycerin, Butylene Glycol, Niacinamide, Titanium Dioxide (CI 77891), Cyclopentasiloxane, Sodium Acrylate/Sodium AcryloyldimethylTaurate Copolymer, Isohexadecane, Polysorbate 80, Dimethiconol, Sodium PolyacryloyldimethylTaurate, Phenoxyethanol, Hydrogenated Polydecene, Chlorphenesin, Ethylhexylglycerin, Caprylyl Glycol, Betaine, Alcohol, Milk Protein Extract, Trideceth-10, Triethoxycaprylylsilane, Adenosine, Disodium EDTA, Fragrance, Sodium Hyaluronate, Tocopheryl Acetate, Theobroma cacao (Cocoa) seed Butter

PURPOSE

Purpose: Skin Protectant

CAUTION

CAUTION: 1. If following problems occur upon using the product, stop use immediately, further use may worsen the symptoms. Consult with a dermatologist if necessary. 1) Red spots, swelling, itchiness, irritation, or any other irregularities. 2) If applied area show above symptoms when exposed to direct sunlight. 2. Do not use on areas shows above symptoms when exposed to direct sunlight. 3. Notes on storage and handling 1) Always put the lid back on after use 2) Keep away from reach of children 3) Keep away from high/ low temperature or direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep away from reach of children

INSTRUCTIONS

INSTRUCTIONS: Anti-wrinkle & brighten cream that daily apply on any parts(face and body) you wish to be brightened up.

Directions

Directions: At the last step of your skin care routine, apply a small amount on neck, arms, legs and any other areas of your body that you wish to brighten your skin tone. Make sure to close the lid after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE WHITE MILK CREA M 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-125
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.75 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propanediol (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-125-021 in 1 CARTON08/20/2016
1NDC:60764-125-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/20/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-125)
Establishment
NameAddressID/FEIBusiness Operations
Cosmecca Korea Co., Ltd.688830827manufacture(60764-125)

Revised: 10/2016
Document Id: 2e36a659-fad4-4951-8e33-052eec2d15f2
Set id: ca49e552-0120-4304-b73e-4b2bd0095bb6
Version: 1
Effective Time: 20161014
 
Nanda Co., Ltd