Eco Earth Power No Sebum Sun by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Drug Details [pdf]

ECO EARTH POWER NO SEBUM SUN- octinoxate, zinc oxide, octisalate, 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.

----------

ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 6.80%, Zinc Oxide 5.00%, Ethylhexyl Salicylate 4.50%, Titanium Dioxide 4.00%

INACTIVE INGREDIENT

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, GLYCERIN, PEG-10 DIMETHICONE, NIACINAMIDE, DICAPRYLYL CARBONATE, SILICA, DIMETHICONE, DISTEARDIMONIUM HECTORITE, CYCLOMETHICONE, MAGNESIUM SULFATE, ALUMINUM HYDROXIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, POLYMETHYL METHACRYLATE, PHENOXYETHANOL, STEARIC ACID, POLYGLYCERYL-6 POLYRICINOLEATE, FRAGRANCE, METHICONE, CAPRYLYL GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, ADENOSINE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, SODIUM HYALURONATE, CALENDULA OFFICINALIS FLOWER EXTRACT, 1,2-HEXANEDIOL, MORINGA OLEIFERA SEED OIL, ALCOHOL, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, LEPIDIUM MEYENII ROOT EXTRACT, CORCHORUS OLITORIUS LEAF EXTRACT, AVERRHOA CARAMBOLA FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT, ETHYLHEXYLGLYCERIN, 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 NO SEBUM SUN
octinoxate, zinc oxide, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-678
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.40 g in 50 g
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.50 g in 50 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.25 g in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.00 g in 50 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: 70341-678-02	1 in 1 CARTON	05/01/2018	11/01/2019
1	NDC: 70341-678-01	50 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
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(70341-678)

Revised: 12/2019

Document Id: e73eed9c-9cd7-482d-94c1-828355322c3b

Set id: c031f63f-56da-44a3-b70e-528eaf7a71da

Version: 2

Effective Time: 20191227

The Saem International Co., Ltd.