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

Drug Details [pdf]

ECO EARTH POWER AQUA SUN- homosalate, octisalate, avobenzone, octocrylene gel
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: Homosalate 7.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 3.00%, Octocrylene 1.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Alcohol Denat., Propanediol, Silica, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Methyl Methacrylate Crosspolymer, Isoamyl p-Methoxycinnamate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Fragrance, Isohexadecane, Ethylhexylglycerin, Tocopheryl Acetate, Sodium Hydroxide, Polysorbate 80, 1,2-Hexanediol, Sorbitan Oleate, Disodium EDTA, Moringa Oleifera Seed Oil, Butylene Glycol, Lepidium Meyenii Root Extract, Calendula Officinalis Flower Extract, Propylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Anthemis Nobilis Flower Extract, Phenoxyethanol, Averrhoa Carambola Fruit Extract, Aloe Barbadensis Leaf Juice, Tocopherol, Sodium Metabisulfite, Potassium Sorbate, Sodium Benzoate

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 carton

ECO EARTH POWER AQUA SUN
homosalate, octisalate, avobenzone, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-684
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	4.20 g in 60 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.70 g in 60 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.80 g in 60 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	0.60 g in 60 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-684-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-684-01	60 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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)

Name	Address	ID/FEI	Business Operations
Establishment
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory		688235645	manufacture(70341-684)

Revised: 12/2019

Document Id: e8e5d1af-9d06-4ad2-b898-271e7df6f17a

Set id: 726a8e2a-e7a0-4776-8b74-07e6775bffcd

Version: 2

Effective Time: 20191227

The Saem International Co., Ltd.