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

Image of cartonImage of carton

ECO EARTH POWER TONE UP SUN 
zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-679
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5.82 g  in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.62 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-679-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-679-0150 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
COSON Co., Ltd._Osan Plant689847210manufacture(70341-679)

Revised: 12/2019
 
The Saem International Co., Ltd.