Label: CLAPIEL MINERAL CC- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69977-030-01 - Packager: AUS KOREA CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 24, 2015
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- ACTIVE INGREDIENT
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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
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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.
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- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLAPIEL MINERAL CC
titanium dioxide, zinc oxide creamProduct 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)
