Edelweiss Pure Sun by Liz Corporation Ltd / WINNOVA Co., Ltd.

Edelweiss Pure Sun by

Drug Labeling and Warnings

Edelweiss Pure Sun by is a Otc medication manufactured, distributed, or labeled by Liz Corporation Ltd, WINNOVA Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EDELWEISS PURE SUN- ethylhexyl methoxycinnamate, ethylhexyl salicylate, homosalate, titanium dioxide cream 
Liz Corporation 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 INGREDIENTS

Ethylhexyl Methoxycinnamate 7.00%
Ethylhexyl Salicylate 3.00%
Homosalate 3.00%
Titanium Dioxide 1.66%

INACTIVE INGREDIENTS

Water, Pentylene Glycol, C12-15 Alkyl Benzoate, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Sorbitan Stearate, Glyceryl Stearate, Butylene Glycol, Ethylhexyl Triazone, Polysorbate 60, PEG-100 Stearate, Stearyl Alcohol, Cetyl Alcohol, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminum Hydroxide, Stearic Acid, Allantoin, Tocopheryl Acetate, Polysorbate 80, Adenosine, Lonicera Japonica (Honeysuckle) Flower Extract, Xanthan Gum, Forsythia Suspensa Fruit Extract, Artemisia Princeps Leaf Extract, Sorbitan Oleate, 1,2-Hexanediol, Glycerin, Leontopodium Alpinum Extract(99ppm), Biosaccharide Gum-4, Myristyl alcohol, Lauryl Alcohol, Leontopodium Alpinum Callus Culture Extract(3ppm), Caprylyl Glycol, Hydroxyacetophenone , Sodium Hyaluronate, Ethylhexylglycerin, Fragrance, Benzyl Alcohol, Citral, Benzyl Salicylate, Linalool, Limonene

PURPOSE

Sunscreen

WARNINGS

Avoid contact with eyes.
Discontinue use if signs of irritation or rashes appear.
Replace the cap after use.
Keep out of reach of children

DESCRIPTION

Uses
Whitening, wrinkling, UV-blocking triple functional cosmetics
Helps prevent sun burn

Directions
Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

Other information

Store at room temperature

QUESTIONS?

+82-31-283-2233 or visit http://www.sheliz.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EDELWEISS PURE SUN 
ethylhexyl methoxycinnamate, ethylhexyl salicylate, homosalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79487-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.5 g  in 50 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	1.5 g  in 50 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.83 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Pentylene Glycol (UNII: 50C1307PZG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79487-020-02	1 in 1 CARTON	07/01/2020	12/30/2020
1	NDC: 79487-020-01	50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2020	12/30/2020

Labeler - Liz Corporation Ltd (694803273)

Registrant - Liz Corporation Ltd (694803273)

Establishment
Name	Address	ID/FEI	Business Operations
WINNOVA Co., Ltd.		689348571	manufacture(79487-020)

Revised: 8/2021

Document Id: 1841490b-2e69-4396-8141-b3ee6ec4f11d

34390-5

Set id: 5ada040e-726a-4160-a502-465d64c14dc0

Version: 3

Effective Time: 20210824