Eco Soul True Moist Pact 21 Light Beige by The Saem International Co., Ltd. / Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory

Eco Soul True Moist Pact 21 Light Beige by

Drug Labeling and Warnings

Eco Soul True Moist Pact 21 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 TRUE MOIST PACT 21 LIGHT BEIGE- titanium dioxide, 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.

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ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 15.02%, Ethylhexyl Methoxycinnamate 4.29%

INACTIVE INGREDIENT

Inactive ingredients:

Talc, Silica, Mica, Magnesium Myristate, Dimethicone, Boron Nitride, Nylon-12, Triethylhexanoin, Phenyl Trimethicone, Magnesium Stearate, CI 77492, Methyl Methacrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydrogenated Polyisobutene, Diisostearyl Malate, Methicone, Barium Sulfate, Alumina, Stearic acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, CI 77491, Triethoxycaprylylsilane, Aluminum Hydroxide, Parfum, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Phenoxyethanol, CI 77007, Chlorphenesin, Water, CI 77499, Tocopheryl Acetate, Alcohol, Butylene Glycol, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, 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:

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 TRUE MOIST PACT 21 LIGHT BEIGE 
titanium dioxide, octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-671
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.65 g  in 11 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.47 g  in 11 g
Inactive Ingredients
Ingredient NameStrength
Talc (UNII: 7SEV7J4R1U)  
Mica (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-671-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-671-0111 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(70341-671)

Revised: 12/2019
Document Id: e706d955-895c-4ad4-bdaf-6c7401373bf4
Set id: 07ac53f1-2866-454b-99b9-5caa2c99051f
Version: 2
Effective Time: 20191228
 
The Saem International Co., Ltd.