ACWELL UV CUT MILD SUN FLUID- titanium dioxide liquid

ACWELL UV CUT Mild Sun Fluid by

Drug Labeling and Warnings

ACWELL UV CUT Mild Sun Fluid by is a Otc medication manufactured, distributed, or labeled by BNHCOSMETICS CO.,LTD., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: TITANIUM DIOXIDE 7.99%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, C12-15 ALKYL BENZOATE, PROPANEDIOL, BUTYLENE GLYCOL, CETYL ETHYLHEXANOATE, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, ALUMINUM STEARATE, POLYMETHYLSILSESQUIOXANE, POLYHYDROXYSTEARIC ACID, BUTYLOCTYL SALICYLATE, SILICA, PENTYLENE GLYCOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VPCOPOLYMER, SACCHARIDE HYDROLYSATE, POLYACRYLATE CROSSPOLYMER-6, BENZOTRIAZOLYL DODECYL P-CRESOL, SODIUM STEAROYL GLUTAMATE, HYDROXYPROPYL METHYLCELLULOSE STEAROXYETHER, GLYCERYL CAPRYLATE, STEARIC ACID, ETHYLHEXYLGLYCERIN, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, CITRUS PARADISI (GRAPEFRUIT) PEEL OIL, PORTULACA OLERACEA EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF OIL, SALVIA HISPANICA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, T-BUTYL ALCOHOL, PERSEA GRATISSIMA (AVOCADO) OIL, ANTHEMIS NOBILIS FLOWER OIL, CENTAUREA CYANUS FLOWER WATER, GLYCERYL GLUCOSIDE, MALTODEXTRIN, HYDROLYZED VEGETABLE PROTEIN, XYLITYLGLUCOSIDE, ANHYDROXYLITOL, XYLITOL, ANIBA ROSODORA (ROSEWOOD) WOOD OIL, GLYCERIN, GLUCOSE, ORIGANUM VULGARE LEAF EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, SCUTELLARIA BAICALENSIS 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
- Avoid contact with eyes.
Please read the instructions carefully prior to use

DESCRIPTION

Uses:
A physical sunscreen contained active mineral ingredients which mainly works by sitting on top of the skin to deflect and scatter damaging UVA rays away from the skin and helps prevent sunburn.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACWELL UV CUT MILD SUN FLUID 
titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71597-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.18 g  in 140 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71597-050-02	1 in 1 CARTON	08/01/2019
1	NDC: 71597-050-01	140 mL in 1 CONTAINER; 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	08/01/2019

Labeler - BNHCOSMETICS CO.,LTD. (688404819)

Registrant - BNHCOSMETICS CO.,LTD. (688404819)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(71597-050)