Blooming Shield Waterful by F&CO Co., Ltd. / COSMAX INC.

Blooming Shield Waterful by

Drug Labeling and Warnings

Blooming Shield Waterful by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLOOMING SHIELD WATERFUL- glycerin cream 
F&CO Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENT: Glycerin (3.0%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Alcohol Denat., Cyclopentasiloxane, Prunus Serrulata Flower Extract, Pentylene Glycol, Silica, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Polyacrylate Starch, Phenoxyethanol, Carbomer, Tromethamine, Trehalose, Fragrance, 1,2-Hexandiol, Dipotassium Glycyrrhizate, Disodium EDTA, Biosaccharide Gum-4, Moringa Pterygosperma Seed Extract, Maltodextrin, Madecassoside, Sodium Hyaluronate, Sccharum Officinarum (Sugar Cane) Extract, Chondrus Crispus Extract, Acid Red 18 (CI 16255)

PURPOSE

PURPOSE: Skin Protectant

WARNINGS

WARNINGS: 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

INDICATIONS & USAGE

Apply a desired amount evenly over entire face.

DOSAGE & ADMINISTRATION

Apply a desired amount evenly over entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLOOMING SHIELD WATERFUL 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	2.7 mg  in 90 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-250-01	90 mL in 1 CARTON; Type 0: Not a Combination Product	03/01/2015	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2015	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69106-250)

Revised: 1/2020

Document Id: 7f89d994-8ad6-4587-8357-3a9f0ec712d4

34390-5

Set id: 94f50fe1-6c80-4809-8503-68d730f5952b

Version: 2

Effective Time: 20200103

 

F&CO Co., Ltd.