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

----------

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

Image of carton

ACWELL UV CUT NATURAL SUN CUSHION 
zinc oxide, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71597-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.87 g  in 25 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.02 g  in 25 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71597-040-021 in 1 CARTON08/01/201910/21/2020
1NDC:71597-040-0125 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/01/201910/21/2020
Labeler - BNHCOSMETICS CO.,LTD. (688404819)
Registrant - BNHCOSMETICS CO.,LTD. (688404819)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(71597-040)

Revised: 6/2021
 
BNHCOSMETICS CO.,LTD.