Eco Earth Power Perfection Waterproof Sun Block by The Saem International Co., Ltd. / Kolmar Korea Co., Ltd.

Eco Earth Power Perfection Waterproof Sun Block by

Drug Labeling and Warnings

Eco Earth Power Perfection Waterproof Sun Block by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ECO EARTH POWER PERFECTION WATERPROOF SUN BLOCK- zinc oxide, octinoxate, 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.

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ACTIVE INGREDIENT

Active ingredients: Zinc Oxide 12.66%, Ethylhexyl Methoxycinnamate 6.80%, Ethylhexyl Salicylate 4.50%, Titanium Dioxide 2.49%

INACTIVE INGREDIENT

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, DIPROPYLENE GLYCOL, BUTYLOCTYL SALICYLATE, PEG-10 DIMETHICONE, GLYCERIN, DISTEARDIMONIUM HECTORITE, METHYL METHACRYLATE CROSSPOLYMER, DIMETHICONE, MAGNESIUM SULFATE, MICA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PHENOXYETHANOL, POLYGLYCERYL-6 POLYRICINOLEATE, FRAGRANCE, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM STEARATE, POLYMETHYLSILSESQUIOXANE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, PROPANEDIOL, GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, IRON OXIDES(CI 77492), MICROCRYSTALLINE CELLULOSE, ALOE BARBADENSIS LEAF JUICE, BUTYLENE GLYCOL, POLYURETHANE-11, PROPYLENE GLYCOL, IRON OXIDES(CI 77491), CELLULOSE GUM, EUTERPE OLERACEA FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, TERMINALIA FERDINANDIANA FRUIT EXTRACT, VISCUM ALBUM (MISTLETOE) LEAF EXTRACT, PORTULACA OLERACEA EXTRACT, CENTELLA ASIATICA EXTRACT, SODIUM HYALURONATE, CALENDULA OFFICINALIS FLOWER EXTRACT, MORINGA OLEIFERA SEED OIL, AMINOPROPYL DIMETHICONE, IRON OXIDES(CI 77499), 1,2-HEXANEDIOL, ALCOHOL, ETHYLHEXYLGLYCERIN, EPILOBIUM ANGUSTIFOLIUM FLOWER/LEAF/STEM EXTRACT, LEPIDIUM MEYENII ROOT EXTRACT, CORCHORUS OLITORIUS LEAF EXTRACT, AVERRHOA CARAMBOLA FRUIT EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT, NELUMBO NUCIFERA FLOWER WATER, POTASSIUM SORBATE, SODIUM BENZOATE, 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 cartonImage of carton

ECO EARTH POWER PERFECTION WATERPROOF SUN BLOCK 
zinc oxide, octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70341-687
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.33 g  in 50 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.40 g  in 50 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.25 g  in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.24 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70341-687-021 in 1 CARTON05/01/201811/01/2019
1NDC: 70341-687-0150 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
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(70341-687)

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