SUNBLOCK CREAM- zinc oxide, octisalate, titanium dioxide cream 
Zhuhai Yasha Medical Instrument 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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50g in a bottle NDC: 80376-001-01

50g Label

SUNBLOCK CREAM 
zinc oxide, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80376-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE9 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 3 g  in 100 g
WATER (UNII: 059QF0KO0R) 45.8 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.2 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80376-001-0150 g in 1 BOTTLE; Type 0: Not a Combination Product08/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/31/2020
Labeler - Zhuhai Yasha Medical Instrument Co., Ltd. (544515023)

Revised: 8/2020
Document Id: ae288ef6-d4ec-1bb9-e053-2995a90aa216
Set id: ae288ef6-d4eb-1bb9-e053-2995a90aa216
Version: 1
Effective Time: 20200831
 
Zhuhai Yasha Medical Instrument Co., Ltd.