Mineralizing Cr eamy Concealer 1.25 Cr eamlatte by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Drug Details [pdf]

MINERALIZING CR EAMY CONCEALER 1.25 CR EAMLATTE- 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.

----------

ACTIVE INGREDIENT

Active ingredients: TITANIUM DIOXIDE 17.43%, ETHYLHEXYL METHOXYCINNAMATE 3.00%, ZINC OXIDE 1.92%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Glycerin, Talc, Dipropylene Glycol, Bis-Hydroxyethoxypropyl Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Hydrogenated Polydecene, Iron Oxides(CI 77492), Niacinamide, Hexyldecyl Myristoyl Methylaminopropionate, Magnesium Sulfate, PEG-10 Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Iron Oxides(CI 77491), Disteardimonium Hectorite, Trihydroxystearin, Aluminum Hydroxide, Iron Oxides(CI 77499), Triethoxycaprylylsilane, Methicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Glyceryl Caprylate, Sorbitan Sesquioleate, Dimethicone, Aluminum Stearate, Olea Europaea (Olive) Fruit Oil, Ethylhexylglycerin, Adenosine, 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, Tocopherol, Macadamia Integrifolia Seed Oil, Vanilla Planifolia Fruit Extract, Elaeis Guineensis (Palm) Oil, 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:

Using the tip applicator, put the concealer on the area where you need coverage. Blend with your finger or a brush.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MINERALIZING CR EAMY CONCEALER 1.25 CR EAMLATTE
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-609
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.69 g in 4 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.12 g in 4 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.07 g in 4 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-609-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-609-01	4 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	05/01/2018	11/01/2019

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(70341-609)

Revised: 12/2019

Document Id: b9c82821-8b3b-432b-81e7-590a1647814b

Set id: 24b89f8e-578d-4e3e-84bf-adfa7dcf5d05

Version: 2

Effective Time: 20191228