Eco Soul Essence Cushion Moisture Lasting 13 by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Eco Soul Essence Cushion Moisture Lasting 13 by

Drug Labeling and Warnings

Eco Soul Essence Cushion Moisture Lasting 13 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 ESSENCE CUSHION MOISTURE LASTING 13- titanium dioxide, octinoxate, octisalate, 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 9.00%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 4.80%, Zinc Oxide 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Rosa Damascena Flower Water, Cyclopentasiloxane, Butylene Glycol Dicaprylate/Dicaprate, Butylene Glycol, Cyclohexasiloxane, C12-15 Alkyl benzoate, PEG-30 Dipolyhydroxystearate, Octocrylene, Canola Oil, Niacinamide, Trimethylsiloxysilicate, Quaternium-18 Bentonite, PEG-10 Dimethicone, Sodium Chloride, Dimethicone, Aluminum Hydroxide, Stearic Acid, CI 77492, Chlorphenesin, Parfum, Phenoxyethanol, Triethoxycaprylylsilane, CI 77491, Adenosine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, CI 77499

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 MOISTURE LASTING 13 
titanium dioxide, octinoxate, octisalate, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-654
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.17 g  in 13 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.91 g  in 13 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.62 g  in 13 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.26 g  in 13 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-654-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-654-0113 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
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(70341-654)

Revised: 12/2019
Document Id: d2b88645-30a7-4eb0-a356-9462b5aff2c7
Set id: 629b4161-6676-47ba-ba27-bf876c942a27
Version: 2
Effective Time: 20191227
 
The Saem International Co., Ltd.