3CE SKIN TONE CONTROL PRIMER PURE VIOLET- 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 3.1%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Butylene Glycol, Triethylhexanoin, Titanium Dioxide (CI 77891), Phenyl Trimethicone, Hexyldecyl Myristoyl Methylaminopropionate, Cyclopentasiloxane, Silica, Mica (CI 77019), Cetyl Dimethicone, Cetearyl Alcohol, Triceteareth-4 Phosphate, Glycol Stearate, Phenoxyethanol, Glyceryl Stearate, PEG-2 Stearate, PEG-100 Stearate, Dimethicone Crosspolymer, Sodium Polyacrylate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Laureth-4, Laureth-23, Ethylhexylglycerin, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Fragrance(Parfum), Ultramarines (CI 77007), Xanthan Gum, Polysorbate 80, Iron Oxides (CI 77499)

PURPOSE

Purpose: Skin Protectant

CAUTION

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

KEEP OUT OF REACH OF CHILDREN

keep it out of children's reach

INSTRUCTIONS

INSTRUCTIONS: This primer helps foundation adhere better on skin and lengthens the longevity of the foundation. Moreover, it gives a brighter skin tone so that you can have a better finish

Directions

Directions: Apply basic makeup such as moisturizer and sunscreen. Then, place primer on face by using a makeup brush or sponge. Pat on lightly for a smooth finish.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

3CE SKIN TONE CONTROL PRIMER PURE VIOLET 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone0.93 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-128-021 in 1 CARTON08/01/2016
1NDC:60764-128-0130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/01/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-128)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-128)

Revised: 10/2016
Document Id: 9f2eb7a8-4e2f-474f-bb50-7c4c41997f7a
Set id: 4ee63d08-8afd-4df3-960c-3d9a4ef26609
Version: 1
Effective Time: 20161014
 
Nanda Co., Ltd