CLAPIEL MINERAL CC- titanium dioxide, zinc oxide cream

Clapiel Mineral CC by

Drug Labeling and Warnings

Clapiel Mineral CC by is a Otc medication manufactured, distributed, or labeled by AUS KOREA CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CLAPIEL MINERAL CC 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69977-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.5 mg  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.1 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69977-030-01	50 mL in 1 CARTON; 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	05/01/2015

Labeler - AUS KOREA CO., LTD. (689515251)

Registrant - AUS KOREA CO., LTD. (689515251)

Establishment
Name	Address	ID/FEI	Business Operations
AUS KOREA CO., LTD.		689515251	manufacture(69977-030)