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

Image of carton

ACWELL SENSITIVE SOLU TION SUN CONTROL 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71597-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.96 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.99 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71597-010-021 in 1 CARTON07/01/201711/01/2019
1NDC: 71597-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/201711/01/2019
Labeler - BNHCOSMETICS CO.,LTD. (688404819)
Registrant - BNHCOSMETICS CO.,LTD. (688404819)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(71597-010)

Revised: 11/2019
 
BNHCOSMETICS CO.,LTD.