Mineralizing Serum Concealer 1.5 Natural Beige by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Mineralizing Serum Concealer 1.5 Natural Beige by

Drug Labeling and Warnings

Mineralizing Serum Concealer 1.5 Natural Beige by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERALIZING SERUM CONCEALER 1.5 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide cream 
The Saem International 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 ingredients: TITANIUM DIOXIDE 10.62%, ETHYLHEXYL METHOXYCINNAMATE 3.00%, ZINC OXIDE 1.92%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Glycerin, Phenyl Trimethicone, Talc, Isododecane, Diisostearyl Malate, Lauryl PEG-10 Tris (Trimethylsiloxy)Silylethyl Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Iron Oxides(CI 77492), Disteardimonium Hectorite, Magnesium Sulfate, Trimethylsiloxysilicate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Silica Dimethyl Silylate, Iron Oxides(CI 77491), Methicone, Iron Oxides(CI 77499), Caprylyl Glycol, Polyglyceryl-6 Polyricinoleate, Glyceryl Caprylate, Aminopropyl Dimethicone, Aluminum Hydroxide, Polymethylsilsesquioxane, Aluminum Stearate, Olea Europaea (Olive) Fruit Oil, Alumina, Ethylhexylglycerin, Adenosine, Silica, Sodium Hyaluronate, Plukenetia Volubilis Seed Oil, Michelia Alba Leaf Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Daucus Carota Sativa (Carrot) Seed Oil, Elettaria Cardamomum Seed Oil, Michelia Alba Flower Oil, Tagetes Minuta Flower Oil, Macadamia Integrifolia Seed Oil, Vanilla Planifolia Fruit Extract, Elaeis Guineensis (Palm) Oil, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Ceramide NP, Phytosphingosine

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings:

For external use only

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.

4. Keep out of reach of babies and children.

DESCRIPTION

Uses:

Helps prevent sunburn.

Directions:

Hold the black part of the concealer with one hand. Then with other hand, twist the container in the right direction. One twist will let out the amount you need for the single application. If you need more, twist once again. Apply with the brush applicator on the needed area, then blend with fingers in patting motion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

MINERALIZING SERUM CONCEALER 1.5 NATURAL BEIGE 
titanium dioxide, octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-605
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.53 g  in 5 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.15 g  in 5 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.19 g  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-605-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-605-015 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/01/201811/01/2019
Labeler - The Saem International Co., Ltd. (689402402)
Registrant - The Saem International Co., Ltd. (689402402)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70341-605)

Revised: 12/2019
 
The Saem International Co., Ltd.