Eco Earth Power Tone Up Sun by The Saem International Co., Ltd. / Coson Co., Ltd._Osan Plant

Eco Earth Power Tone Up Sun by

Drug Labeling and Warnings

Eco Earth Power Tone Up Sun by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Coson Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO EARTH POWER TONE UP SUN- zinc oxide, titanium dioxide 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: Zinc Oxide 11.64%, Titanium Dioxide 3.25%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Propanediol, Dicaprylyl Carbonate, PEG-10 Dimethicone, Dimethicone, Disteardimonium Hectorite, Pentylene Glycol, Magnesium Sulfate, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrogen Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, Fragrance, Sorbitan Sesquioleate, Fructooligosaccharides, Saccharide Hydrolysate, Aluminum Hydroxide, Pullulan, Triethoxycaprylylsilane, 1,2-Hexanediol, Ethylhexylglycerin, Octyldodecanol, Stearic Acid, Lepidium Meyenii Root Extract, Alcohol, Glycerin, Echium Plantagineum Seed Oil, Epilobium Angustifolium Flower/Leaf/Stem Extract, Butylene Glycol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Averrhoa Carambola Fruit Extract, Moringa Pterygosperma Seed Extract, Tocopherol, Maltodextrin

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:

At the last step of skin care, apply on the skin area exposed to UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ECO EARTH POWER TONE UP SUN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-679
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	5.82 g  in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.62 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-679-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-679-01	50 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
COSON Co., Ltd._Osan Plant		689847210	manufacture(70341-679)

Revised: 12/2019

Document Id: 2c7af35a-fd3e-4a60-afbe-d29fc88d5df7

34390-5

Set id: 62bae1b9-76fa-4bb4-bc9c-a4a923393d0a

Version: 2

Effective Time: 20191227

 

The Saem International Co., Ltd.