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

Blooming Shield Blossom Mist by

Drug Labeling and Warnings

Blooming Shield Blossom Mist 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 BLOSSOM MIST- butylene glycol spray 
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.

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ACTIVE INGREDIENT

ACTIVE INGREDIENT: Butylene Glycol (2.4%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Water, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Serrulata Flower Extract, Glycerin, PEG/PPG-17/6 Copolymer, Phenoxyethanol, Behenyl Alcohol, Butyrospermum Parkii (Shea) Butter, Biosaccharide Gum-4, Arginine, Carbomer, 1,2-Hexandiol, Fragrance, Polyglutamic Acid, Madecassoside, Moringa Pterygosperma Seed Extract, Maltodextrin

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 BLOSSOM MIST 
butylene glycol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-240
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Butylene Glycol (UNII: 3XUS85K0RA) (BUTYLENE GLYCOL - UNII:3XUS85K0RA)	Butylene Glycol	1.92 mg  in 80 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Pentylene Glycol (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-240-01	80 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(69106-240)

Revised: 1/2020

Document Id: 2ddd939e-c208-41b8-bb35-97980fcca30c

34390-5

Set id: edc449e3-0f42-4dd4-8cd4-a5e457fcd02d

Version: 3

Effective Time: 20200103

 

F&CO Co., Ltd.