Eco Soul Bounce Crea m Foundation Matte 02 Natural Beige by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Eco Soul Bounce Crea m Foundation Matte 02 Natural Beige by

Drug Labeling and Warnings

Eco Soul Bounce Crea m Foundation Matte 02 Natural Beige by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO SOUL BOUNCE CREA M FOUNDATION MATTE 02 NATURAL BEIGE- titanium dioxide powder 
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 12.0%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Dimethicone, Trimethylsiloxysilicate, Octyldodecanol, Butylene Glycol, PEG/PPG-18/18 Dimethicone, Niacinamide, CI 77492, PEG-10 Dimethicone, Quaternium-18 Bentonite, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Polymethyl Methacrylate, Sodium Chloride, Disteardimonium Hectorite, CI 77491, Triethoxycaprylylsilane, Aluminum Hydroxide, Chlorphenesin, CI 77499, Propylene Carbonate, Parfum, Adenosine, 1,2-Hexanediol, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Thymus Vulgaris (Thyme) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Rosa Canina Fruit Extract, Origanum Majorana Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Water

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:

Apply appropriate amount on a puff and gently apply on the entire face followed by skin texture, tap lightly to finish.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECO SOUL BOUNCE CREA M FOUNDATION MATTE 02 NATURAL BEIGE 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-641
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.80 g  in 15 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-641-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-641-01	15 g in 1 CONTAINER; 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	05/01/2018	11/01/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-641)

Revised: 12/2019

Document Id: bdbebfd4-4ed1-417e-ba47-dbec1a7e0fe5

34390-5

Set id: 4aedbf05-1201-477e-8bab-8f5381c4bd06

Version: 3

Effective Time: 20191227