ECO SOUL Essence Cushion Matt Longwear 21 by The Saem International Co., Ltd. / Cosmax, Inc.

ECO SOUL Essence Cushion Matt Longwear 21 by

Drug Labeling and Warnings

ECO SOUL Essence Cushion Matt Longwear 21 by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO SOUL ESSENCE CUSHION MATT LONGWEAR 21- titanium dioxide, zinc oxide, octinoxate 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 9.05%, Zinc Oxide 3.92%, Ethylhexyl Methoxycinnamate 3.50%

INACTIVE INGREDIENT

Inactive ingredients:

Talc, Mica (CI 77019), Synthetic Fluorphlogopite, Silica, Alumina, Dimethicone, Trimethylolpropane Triethylhexanoate, HDI/Trimethylol Hexyllactone Crosspolymer, Lauroyl Lysine, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Magnesium Myristate, Ethylhexylglycerin, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Glyceryl Caprylate, Methicone, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Hydrogen Dimethicone, Acrylates/Tridecyl Acrylate/Triethoxysilylpropyl Methacrylate/Dimethicone Methacrylate Copolymer, Synthetic Beeswax, Iron Oxides (CI 77499), Hydroxypropyl Bispalmitamide MEA, Fragrance(Parfum), Ultramarines (CI 77007), Water, Alcohol, Achillea Millefolium Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Gentiana Lutea Root Extract, 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:

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

Image of cartonImage of carton

ECO SOUL ESSENCE CUSHION MATT LONGWEAR 21 
titanium dioxide, zinc oxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.35 g  in 15 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.58 g  in 15 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.52 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Talc (UNII: 7SEV7J4R1U)  
Mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-652-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-652-0115 g 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
Cosmax, Inc.689049693manufacture(70341-652)

Revised: 12/2019
Document Id: 6f011a25-f560-4d67-9c1f-c3d0fc757b79
Set id: b4e5eb70-1913-4d50-a650-548988a6ce7f
Version: 2
Effective Time: 20191227
 
The Saem International Co., Ltd.