OTC Medication Information: ACWELL UV CUT Natural Sun Cushion

ACWELL UV CUT NATURAL SUN CUSHION- zinc oxide and 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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 2.87 g in 25 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.02 g in 25 g
Inactive Ingredients
Ingredient Name Strength
Water
PROPYLHEPTYL CAPRYLATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71597-040-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71597-040-01)
1 NDC:71597-040-01 25 g in 1 CONTAINER This package is contained within the CARTON (71597-040-02)
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 Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory 689512611 manufacture (71597-040)

Revised: 09/2019 BNHCOSMETICS CO.,LTD.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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