Eco Soul UV Sun Pact 21 Light Beige by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Eco Soul UV Sun Pact 21 Light Beige by

Drug Labeling and Warnings

Eco Soul UV Sun Pact 21 Light Beige by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO SOUL UV SUN PACT 21 LIGHT BEIGE- zinc oxide, 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: Zinc Oxide 14.40%, Titanium Dioxide 9.96%, Ethylhexyl Methoxycinnamate 5.00%

INACTIVE INGREDIENT

Inactive ingredients:

TALC, SILICA, SYNTHETIC FLUORPHLOGOPITE, POLYMETHYL METHACRYLATE, ETHYLENE/ACRYLIC ACID COPOLYMER, ZINC MYRISTATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, ALUMINUM HYDROXIDE, STEARIC ACID, IRON OXIDES(CI 77492), DIMETHICONE, 1,2-HEXANEDIOL, AMINOPROPYL DIMETHICONE, POLYMETHYLSILSESQUIOXANE, IRON OXIDES(CI 77491), GLYCERYL CAPRYLATE, METHICONE, FRAGRANCE, IRON OXIDES(CI 77499), TRIETHOXYCAPRYLYLSILANE, ALEURITES MOLUCCANA SEED OIL, MORINGA OLEIFERA SEED OIL, HDI/PPG/POLYCAPROLACTONE CROSSPOLYMER, TOCOPHEROL

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:

Take an appropriate amount with puff and apply all over the face in a gentle tapping motion. Apply as often as needed to protect skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECO SOUL UV SUN PACT 21 LIGHT BEIGE 
zinc oxide, titanium dioxide, octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-666
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.58 g  in 11 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.09 g  in 11 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.55 g  in 11 g

Inactive Ingredients
Ingredient Name	Strength
TALC (UNII: 7SEV7J4R1U)
ZINC MYRISTATE (UNII: K09A9E2GGO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-666-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-666-01	11 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
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(70341-666)

Revised: 12/2019

Document Id: 215d0e23-d373-464f-b7b3-7ffe541d80b7

34390-5

Set id: 8e499565-bd13-48df-ab0d-fb163332bcdb

Version: 2

Effective Time: 20191228

 

The Saem International Co., Ltd.