ACWELL SENSITIVE SOLU TION SUN CONTROL by BNHCOSMETICS CO.,LTD. / Cosmax, Inc

ACWELL SENSITIVE SOLU TION SUN CONTROL by

Drug Labeling and Warnings

ACWELL SENSITIVE SOLU TION SUN CONTROL by is a Otc medication manufactured, distributed, or labeled by BNHCOSMETICS CO.,LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACWELL SENSITIVE SOLU TION SUN CONTROL- zinc oxide, titanium dioxide cream 
BNHCOSMETICS 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: Zinc Oxide 13.92%, Titanium Dioxide 7.98%

INACTIVE INGREDIENT

Inactive ingredients: Cyclopentasiloxane,Water,PEG-10 Dimethicone,Butylene Glycol,Dipropylene Glycol,Ethylhexyl Palmitate,Cyclohexasiloxane,Cetyl PEG/PPG-10/1 Dimethicone,Caprylyl Methicone,Sodium Chlorid,Dimethicone,Aluminum Hydroxide,Disteardimonium Hectorite,Methyl Methacrylate Crosspolymer,Stearic Acid,Dimethicone/Methicone Copolymer,Sorbitan Sesquioleate,Fragrance(Parfum),Glyceryl Caprylate,Phenoxyethanol,Trimethylsiloxysilicate,Caprylyl Glycol,Disodium EDTA,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Talc,Rehmannia Glutinosa Root Extract,Glycyrrhiza Glabra (Licorice) Root Extract,Ophiopogon Japonicus Root Extract,Phellodendron Amurense Bark Extract,Paeonia Albiflora Root Extract,Anemarrhena Asphodeloides Root Extract,Angelica Acutiloba Root Extract,Rehmannia Chinensis Root Extract

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

 -For external use only -Do not use on skin that is broken, irritated or eczema -Stop using and consult with your doctor or dermatologist if any of the following signs or symptoms occur after using this product -You experience redness, swelling, itchiness, irritation or other discomfort -When the symptoms listed above occur after exposure to direct rays -Directions for storage and handling -Do not store in hot or cold temperatures, or under direct rays

Please read the instructions carefully prior to use

DESCRIPTION

Uses: MILD SUNCARE FOR SENSITIVE SKIN USING MINERAL FILTERS

Directions: Apply an adequate amount evenly on your skin commonly exposed to UV rays

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACWELL SENSITIVE SOLU TION SUN CONTROL 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71597-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	6.96 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.99 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71597-010-02	1 in 1 CARTON	07/01/2017	11/01/2019
1	NDC: 71597-010-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2017	11/01/2019

Labeler - BNHCOSMETICS CO.,LTD. (688404819)

Registrant - BNHCOSMETICS CO.,LTD. (688404819)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(71597-010)

Revised: 11/2019

Document Id: 963d48b5-3af7-438e-9e69-1aab69f2eb49

34390-5

Set id: 61dc51bb-e4de-41d9-832b-f58640bb7db2

Version: 2

Effective Time: 20191128

 

BNHCOSMETICS CO.,LTD.