WATERFUL ESSENCE SUN- octinoxate, homosalate, octisalate cream

Waterful Essence Sun by

Drug Labeling and Warnings

Waterful Essence Sun by is a Otc medication manufactured, distributed, or labeled by BMONUMENT Co., Ltd, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate, Homosalate, Ethyhexyl Salicylate, Niacinamide, Adenosine

INACTIVE INGREDIENT

Water, etc

PURPOSE

• Sunscreen
• Whitening
• Anti-Wrinkle

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

WARNINGS

1. In case of getting red spots, inflation or itching side-effects while or after using the products
contact a doctor right away.
2. Do not use on damaged or broken skin.
3. Handling and storage precautions
(1) Keep out of reach of children
(2) Keep away from direcct sunlight

INDICATIONS & USAGE

Apply a small amount of cream on the face and gently pat the skin at the last stage of skincare.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WATERFUL ESSENCE SUN 
octinoxate, homosalate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72293-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72293-0001-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/04/2018

Labeler - BMONUMENT Co., Ltd (694624625)

Registrant - BMONUMENT Co., Ltd (694624625)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(72293-0001) , label(72293-0001) , pack(72293-0001)

Establishment
Name	Address	ID/FEI	Business Operations
BMONUMENT Co., Ltd		694624625	relabel(72293-0001)