Snail Essential EX Wrinkle Sun by The Saem International Co., Ltd.

Snail Essential EX Wrinkle Sun by

Drug Labeling and Warnings

Snail Essential EX Wrinkle Sun by is a Otc medication manufactured, distributed, or labeled by The Saem International Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SNAIL ESSENTIAL EX WRINKLE 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.

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ACTIVE INGREDIENT

Active Ingredients: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ZINC OXIDE 5.0%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 4.0%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, DICAPRYLYL CARBONATE, NIACINAMIDE, DIMETHICONE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, ALUMINUM HYDROXIDE, ALOE BARBADENSIS LEAF JUICE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, PORTULACA OLERACEA EXTRACT, PHENOXYETHANOL, STEARIC ACID, FRAGRANCE, METHICONE, CAPRYLYL GLYCOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, SNAIL SECRETION FILTRATE, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, ADENOSINE, SODIUM HYALURONATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, HYDROGENATED LECITHIN, CERAMIDE 3, CHOLESTEROL

PURPOSE

Purpose: Sunscreen

WARNINGS

Warning: 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.

DESCRIPTION

Keep out of reach of Children: Keep out of reach of babies and children

Indication & Usage: Take an adequate amount of sun cream and gently spread out on whole face.

Dosage & Administration: Take an adequate amount of this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SNAIL ESSENTIAL EX WRINKLE SUN 
octinoxate, zinc oxide, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70341-110
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.06 g  in 45 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.25 g  in 45 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.02 g  in 45 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.80 g  in 45 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70341-110-01	45 mL in 1 CARTON; Type 0: Not a Combination Product	12/01/2015	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2015	11/01/2019

Labeler - The Saem International Co., Ltd. (689402402)

Registrant - The Saem International Co., Ltd. (689402402)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(70341-110)

Revised: 12/2019

Document Id: 90363ac9-cd88-4e23-a905-5dbcad688616

34390-5

Set id: 89ba774a-9e84-4781-9f0a-198eff7275c9

Version: 2

Effective Time: 20191230

 

The Saem International Co., Ltd.