Eco Soul Bounce Crea m Foundation 01 Light Beige by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Eco Soul Bounce Crea m Foundation 01 Light Beige by

Drug Labeling and Warnings

Eco Soul Bounce Crea m Foundation 01 Light 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 01 LIGHT BEIGE- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide 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.

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ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 9.02%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.80%, Octocrylene 2.00%, Zinc Oxide 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, C12-15 Alkyl benzoate, PEG-30 Dipolyhydroxystearate, Niacinamide, Trimethylsiloxysilicate, Quaternium-18 Bentonite, PEG-10 Dimethicone, Bis-Diglyceryl Polyacyladipate-2, Polymethyl Methacrylate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sodium Chloride, Dimethicone, Copernicia Cerifera (Carnauba) Wax, Ozokerite, Iron Oxides (CI 77492), Aluminum Hydroxide, Chlorphenesin, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Stearic Acid, Perfume, Iron Oxides (CI 77499), Adenosine, Rosa centifolia flower water, Erythritol, Soluble Collagen, Xylitylglucoside, Anhydroxylitol, Glycerin, Xylitol, Pentylene Glycol, Citrullus Vulgaris (Watermelon) Fruit Extract, Phenoxyethanol, Glucose, 1,2-Hexanediol, Caprylyl Glycol, Hydrolyzed Collagen Extract, Sodium Hyaluronate, Citrulline, Sodium Benzoate, Potassium Sorbate, Aloe Barbadensis Leaf Extract, Hydrolyzed Hyaluronic Acid

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 01 LIGHT BEIGE 
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-638
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.35 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.05 g  in 15 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.72 g  in 15 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	0.30 g  in 15 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.30 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: 70341-638-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-638-01	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(70341-638)

Revised: 12/2019

Document Id: 426e7ed0-7b15-436d-9e04-0133f380b889

34390-5

Set id: e01f1b38-b41a-4c1b-8853-1c1a96c5bd87

Version: 2

Effective Time: 20191227

 

The Saem International Co., Ltd.