PRIME PRIMER HYDRATING FINISH by F&CO Co., Ltd.

PRIME PRIMER HYDRATING FINISH by

Drug Labeling and Warnings

PRIME PRIMER HYDRATING FINISH by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRIME PRIMER HYDRATING FINISH- dimethicone powder 
F&CO 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: Dimethicone 15.47%

INACTIVE INGREDIENT

Inactive ingredients:
Silica, Mica (CI 77019), boron Nitride, Macadamia Ternifolia Seed Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenyl Trimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Diisostearyl Malate, Ultramarines (CI 77007), Ethylhexylglycerin, Lauroyl Lysine, Dimethicone/PEG-10/15 Crosspolymer, Glyceryl Caprylate, Iron Oxides (CI 77492), Triethoxycaprylylsilane, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Water, Fragrance(Parfum), Montmorillonite, Aloe Barbadensis Leaf Extract, Methicone, Rosa Centifolia Flower Water, Butylene Glycol, Lonicera Japonica (Honeysuckle) Flower Extract, Aspalathus Linearis Extract, Lilium Candidum Flower Extract, Borago Officinalis Extract, Salvia Officinalis (Sage) Leaf Extract, Centaurea Cyanus Flower Extract, Anthemis Nobilis Flower Extract, Phenoxyethanol, Cucumis Sativus (Cucumber) Fruit Extract, Caprylyl Glycol, Onsen-sui

PURPOSE

Purpose: Skin protectant

CAUTION

CAUTION:
If redness or irritation occurs, discontinue use and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

How to Use

How to Use: Apply it over makeup to extend wear or simply roll the brush over the face to minimize the appearance of pores and fine lines; or apply by pressing and rolling the puff onto the skin.

Dosage & Administration

Dosage & Administration:
Formulated with mineral base of Pure Nature Complex & Green Clay, this weightless, translucent setting powder creates a soft matte finish with a luminous glow, extending makeup wear without dehydrating.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRIME PRIMER HYDRATING FINISH 
dimethicone powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-140
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	1.85 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
Mica (UNII: V8A1AW0880)
MACADAMIA OIL (UNII: 515610SU8C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-140-01	12 g in 1 CARTON; Type 0: Not a Combination Product	07/01/2014	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/01/2014	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

Registrant - F&CO Co., Ltd. (690166186)

Establishment
Name	Address	ID/FEI	Business Operations
F&CO Co., Ltd.		690166186	manufacture(69106-140)

Revised: 1/2020

Document Id: 4d97b7eb-9a3f-49f2-a4c1-3e1764512c7b

34390-5

Set id: e10d9cd3-2f1e-4571-8ca9-47447675eb87

Version: 2

Effective Time: 20200109

 

F&CO Co., Ltd.