Eco Earth Power Face and Body Waterproof Sun Block by The Saem International Co., Ltd. / Cosmax, Inc.

Drug Details [pdf]

ECO EARTH POWER FACE AND BODY WATERPROOF SUN BLOCK- zinc oxide, octinoxate, titanium dioxide, octisalate, octocrylene 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 7.84%, Ethylhexyl Methoxycinnamate 7.00%, Titanium Dioxide 4.56%, Ethylhexyl Salicylate 4.50%, Octocrylene 2.00%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Cyclohexasiloxane, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Methyl Methacrylate Crosspolymer, Sorbitan Isostearate, Aluminum Hydroxide, Stearic Acid, Disteardimonium Hectorite, Phenoxyethanol, Fragrance(Parfum), Caprylyl Glycol, Silica Dimethyl Silylate, Dimethicone, Ethylhexylglycerin, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Lepidium Meyenii Root Extract, Moringa Oleifera Seed Oil, Averrhoa Carambola Fruit Extract, Butylene Glycol, Epilobium Angustifolium Flower/Leaf/Stem Extract, Gentiana Scabra Root Extract, Sodium Benzoate, Citric Acid, Tocopherol

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 FACE AND BODY WATERPROOF SUN BLOCK
zinc oxide, octinoxate, titanium dioxide, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-688
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7.84 g in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.00 g in 100 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.56 g in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	4.50 g in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2.00 g in 100 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 70341-688-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-688-01	100 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
Cosmax, Inc.		689049693	manufacture(70341-688)

Revised: 12/2019

Document Id: d251567a-b547-48bb-a0a1-b5eaccd683d8

Set id: 9435b425-cf06-4150-b6bb-f23f5fea489a

Version: 2

Effective Time: 20191227

The Saem International Co., Ltd.