ECO EARTH POWER MILD SUN CUSHION- zinc oxide, titanium dioxide 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 9.70%, Titanium Dioxide 5.95%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Acrylates Copolymer, Glycerin, Diphenylsiloxy Phenyl Trimethicone, Caprylyl Methicone, C12-15 Alkyl Benzoate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Cyclohexasiloxane, Sodium Chloride, Cetyl PEG/PPG-10/1 Dimethicone, Methyl Methacrylate Crosspolymer, Mica (CI 77019), Silica, Cetearyl Dimethicone/Vinyl Dimethicone Crosspolymer, Boron Nitride, Disteardimonium Hectorite, Polymethyl Methacrylate, Fragrance(Parfum), Triethoxycaprylylsilane, Isododecane, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Glyceryl Caprylate, Caprylyl Glycol, Disodium EDTA, Aloe Barbadensis Leaf Extract, Moringa Oleifera Seed Oil, Caprylic/Capric Triglyceride, Calendula Officinalis Flower Extract, Tocopherol, Propanediol, Averrhoa Carambola Fruit Extract, Lepidium Meyenii Root Extract, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Gentiana Scabra Root Extract, Sodium Benzoate, Pentylene Glycol, Citric Acid, 1,2-Hexanediol, Octanediol, Ethylhexylglycerin

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 by pressing the puff into the moistened sponge and patting the puff onto the face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

ECO EARTH POWER MILD SUN CUSHION 
zinc oxide, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70341-681
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.45 g  in 15 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.89 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70341-681-021 in 1 CARTON05/01/201811/01/2019
1NDC:70341-681-0115 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
Cosmax, Inc.689049693manufacture(70341-681)

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