ACWELL UV CUT NATURAL SUN CUSHION- zinc oxide, titanium dioxide powder

ACWELL UV CUT Natural Sun Cushion by

Drug Labeling and Warnings

ACWELL UV CUT Natural Sun Cushion 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: ZINC OXIDE 11.50%, TITANIUM DIOXIDE 4.10%

INACTIVE INGREDIENT

Inactive ingredients:
WATER, PROPYLHEPTYL CAPRYLATE, DICAPRYLYL ETHER, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, POLYGLYCERYL-4DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE, PROPANEDIOL, GLYCERIN, SILICA, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, STEARIC ACID, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, POLYGLYCERYL-6 POLYRICINOLEATE, SORBITAN CAPRYLATE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, TOCOPHEROL, FRUCTAN, BUTYLENE GLYCOL, CHAMOMILLA RECUTITA (MATRICARIA) FLOWERWATER, ORIGANUM VULGARE LEAF EXTRACT, CHAMAECYPARIS OBTUSA LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAFEXTRACT, OCIMUM BASILICUM (BASIL) LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, ANTHEMIS NOBILIS FLOWER 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 NATURAL SUN CUSHION 
zinc oxide, titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71597-040
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.87 g  in 25 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.02 g  in 25 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71597-040-02	1 in 1 CARTON	08/01/2019
1	NDC: 71597-040-01	25 g 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(71597-040)