Eco Soul Real Fit Foundation 23 Rich Beige by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Eco Soul Real Fit Foundation 23 Rich Beige by

Drug Labeling and Warnings

Eco Soul Real Fit Foundation 23 Rich 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 REAL FIT FOUNDATION 23 RICH BEIGE- titanium dioxide, octinoxate 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 11.47%, Ethylhexyl Methoxycinnamate 1.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Dimethicone, Phenyl Trimethicone, Octyldodecanol, PEG-10 Dimethicone, CI 77492, Niacinamide, Quaternium-18 Bentonite, Butylene Glycol, Sorbitan Sesquioleate, Stearic Acid, Sodium Chloride, CI 77491, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Disteardimonium Hectorite, Triethoxycaprylylsilane, Parfum, Aluminum Hydroxide, Chlorphenesin, CI 77499, Phenoxyethanol, Propylene Carbonate, Adenosine, Alcohol, Arnica Montana Flower Extract, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Artemisia Vulgaris Extract, Propylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Potassium Sorbate

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 cartonImage of carton

ECO SOUL REAL FIT FOUNDATION 23 RICH BEIGE 
titanium dioxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-637
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.58 g  in 40 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.40 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-637-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-637-0140 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
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-637)

Revised: 12/2019
Document Id: 5cbc690a-dc1b-42bd-9983-98f90fe4c01b
Set id: 9a2e56f6-7e8c-4c9f-bc58-7364bd2524ee
Version: 2
Effective Time: 20191227
 
The Saem International Co., Ltd.