WATERFUL ESSENCE SUN- octinoxate, homosalate, octisalate cream 
BMONUMENT 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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Drug Facts

Ethylhexyl Methoxycinnamate, Homosalate, Ethyhexyl Salicylate, Niacinamide, Adenosine

Water, etc

  • Sunscreen
  • Whitening
  • Anti-Wrinkle

keep out of reach of the children

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

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

for external use only


label

WATERFUL ESSENCE SUN 
octinoxate, homosalate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72293-0001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72293-0001-150 mL in 1 TUBE; Type 0: Not a Combination Product05/04/201805/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/04/201805/13/2023
Labeler - BMONUMENT Co., Ltd (694624625)
Registrant - BMONUMENT Co., Ltd (694624625)
Establishment
NameAddressID/FEIBusiness Operations
BMONUMENT Co., Ltd694624625manufacture(72293-0001)

Revised: 5/2023
Document Id: fb897372-f3d8-f3b1-e053-6394a90a857d
Set id: 6b590c72-124d-6f45-e053-2991aa0a8af6
Version: 3
Effective Time: 20230512
 
BMONUMENT Co., Ltd