CLAPIEL MINERAL CC- titanium dioxide, zinc oxide cream 
AUS KOREA 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 Ingredient: Titanium Dioxide 5.0%, Zinc Oxide 0.2%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cetyl Ethylhexanoate, Caprylic/Capric Triglyceride, Propylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, 1,2-Hexanediol, Zinc Stearate, Silica Dimethyl Silylate, Linum Usitatissimum (Linseed) Seed Oil, Magnesium Sulfate, Sodium Hyaluronate, Sorbitan Sesquioleate, Hydroxyethylcellulose, Pichia Anomala Extract, Yeast Extract, Hydrolyzed Myrtus Communis Leaf Extract, Undaria Pinnatifida Extract, Myrothamnus Flabellifolia Callus Culture Extract, Pentylene Glycol, Lactuca Indica Extract, Corydalis Ochotensis Extract, Draba Nemorosa Extract, Chenopodium Album Flower Extract, Lactobacillus/Soybean Ferment Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Scutellaria Baicalensis Root Extract, Portulaca Oleracea Extract, Microcrystalline Wax, Allantoin, Beta-Glucan, Tocopheryl Acetate, Ultramarines, CI 77499, CI 77491, CI 77492

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of babies and children

DESCRIPTION

Indications & Usage: Apply a desired amount evenly over entire face.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

CLAPIEL MINERAL CC 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69977-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.5 mg  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.1 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69977-030-0150 mL in 1 CARTON; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/2015
Labeler - AUS KOREA CO., LTD. (689515251)
Registrant - AUS KOREA CO., LTD. (689515251)
Establishment
NameAddressID/FEIBusiness Operations
AUS KOREA CO., LTD.689515251manufacture(69977-030)

Revised: 7/2015
Document Id: a8c9dd1d-7307-414e-87c8-cad3cde0ee4f
Set id: cdab8cbb-1669-4eb0-82df-4afd1461d971
Version: 1
Effective Time: 20150724
 
AUS KOREA CO., LTD.