ACWELL AQUA CAP SULE SUN CONTROL by BNHCOSMETICS CO.,LTD. / Cosmax, Inc

ACWELL AQUA CAP SULE SUN CONTROL by

Drug Labeling and Warnings

ACWELL AQUA CAP SULE 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 AQUA CAP SULE SUN CONTROL- octinoxate, octisalate, avobenzone gel 
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: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 4.5%, Butyl Methoxydibenzoylmethane 3.0%

INACTIVE INGREDIENT

Inactive ingredients: Water,Butylene Glycol,Behenyl Alcohol,Glycerin,Dicaprylyl Carbonate,Neopentyl Glycol Diheptanoate,Pentylene Glycol,Benzotriazolyl Dodecyl p-Cresol,Methyl Methacrylate Crosspolymer,Hydroxyacetophenone,Carbomer,Fragrance(Parfum),Tromethamine,Caprylyl Glycol,Dehydroxanthan Gum,Gellan Gum,Glyceryl Caprylate,Ethylhexylglycerin,Disodium EDTA,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

Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

Keep Out of Reach of Children

DESCRIPTION

Uses: TRANSPARENT SUN GEL WITH FRESH MOISTURE

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ACWELL AQUA CAP SULE SUN CONTROL 
octinoxate, octisalate, avobenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71597-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.50 g  in 50 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.50 g  in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.25 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: 71597-030-02	1 in 1 CARTON	07/01/2017	11/01/2019
1	NDC: 71597-030-01	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(71597-030)

Revised: 11/2019

Document Id: 30ea6b90-9af4-4220-b7ea-c89838e33c80

34390-5

Set id: 5640d6a5-43b4-48ed-bc45-f1b18e6c64e9

Version: 2

Effective Time: 20191128

 

BNHCOSMETICS CO.,LTD.