Saemmul Cover Foundation 01 Light Beige by The Saem International Co., Ltd. / Cosmecca Korea Co., Ltd.

Drug Details [pdf]

SAEMMUL COVER FOUNDATION 01 LIGHT BEIGE- titanium dioxide, 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 13.38%, ZINC OXIDE 1.44%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Dimethicone, Butylene Glycol, Cyclohexasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Diethylhexyl Carbonate, Glycerin, Phenyl Trimethicone, PEG-10 Dimethicone, Alcohol Denat., Niacinamide, Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides (CI 77492), Cetyl PEG/PPG-10/1 Dimethicone, Methyl Methacrylate Crosspolymer, PEG-10 Methyl Ether Dimethicone, Talc, Disteardimonium Hectorite, 1,2-Hexanediol, Iron Oxides (CI 77491), Caprylyl Glycol, Triethyl Citrate, Triethoxycaprylylsilane, Fragrance, Tocopheryl Acetate, Disodium EDTA, Betula Platyphylla Japonica Juice, Iron Oxides (CI 77499), Hydrogen Dimethicone, Ethylhexylglycerin, Adenosine, Propylene Glycol, Ethoxydiglycol, Rosa Centifolia Flower Water, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Equisetum Arvense Extract, Adansonia Digitata Seed Extract, Sophora Japonica Flower Extract, Pentylene Glycol, Fructan, Nelumbo Nucifera Flower Water, Ceramide NP, Sodium Hyaluronate

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:

Use after your skincare routine. Apply an appropriate amount evenly on the face along skin's texture and gently tap for better coverage.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SAEMMUL COVER FOUNDATION 01 LIGHT BEIGE
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-620
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.00 g in 15 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.21 g in 15 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-620-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-620-01	15 mL in 1 TUBE; 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
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-620)

Revised: 12/2019

Document Id: e51299ae-81a4-483c-82f4-5cac4dbfa1a3

Set id: 81877218-4e5e-4143-aeea-8b241d848114

Version: 2

Effective Time: 20191230

The Saem International Co., Ltd.