Eco Earth Power Mild Kids Sun by The Saem International Co., Ltd. / Cosmecca Korea Co., Ltd.

Eco Earth Power Mild Kids Sun by

Drug Labeling and Warnings

Eco Earth Power Mild Kids Sun by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Cosmecca Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO EARTH POWER MILD KIDS 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 4.80%, Titanium Dioxide 4.15%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Caprylic/Capric Triglyceride, Butylene Glycol, Caprylyl Methicone, Propanediol, Cetyl Ethylhexanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cetearyl Alcohol, C20-22 Alkyl Phosphate, Dimethicone, Squalane, C20-22 Alcohols, Microcrystalline Cellulose, Polysorbate 60, Coco-glucoside, Aluminum Hydroxide, Stearic Acid, Fragrance, Phenoxyethanol, Glycerin, Hydrogen Dimethicone, Sodium Benzoate, Cellulose Gum, Disodium EDTA, Tocopheryl Acetate, Potassium Sorbate, Alcohol, Moringa Oleifera Seed Oil, Sodium Hyaluronate, Lepidium Meyenii Root Extract, Propylene Glycol, Calendula Officinalis Flower Extract, Ethylhexylglycerin, Epilobium Angustifolium Flower/Leaf/Stem Extract, Anthemis Nobilis Flower Extract, Citrus Aurantifolia (Lime) Oil, Eucalyptus Globulus Leaf Oil, Averrhoa Carambola Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Oil, Aloe Barbadensis Leaf Juice, Tocopherol, Sodium Metabisulfite, Aniba Rosaeodora (Rosewood) Wood Oil

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 MILD KIDS SUN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-682
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.88 g  in 60 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.49 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-682-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-682-01	60 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
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-682)

Revised: 12/2019

Document Id: 6430a086-56e8-49d6-b6b5-4cf371c160fd

34390-5

Set id: 886bdcd6-9fe2-4fca-8919-9183afe00b26

Version: 2

Effective Time: 20191227

 

The Saem International Co., Ltd.