SKINFUSE SHIELD SPF 30- zinc oxide cream 
Owen Biosciences, Inc.

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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Skinfuse Shield 30g

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SKINFUSE SHIELD  SPF 30
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-240
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 34 g  in 100 g
ETHYL MACADAMIATE (UNII: ANA2NCS6V1) 5 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T) 5 g  in 100 g
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) 4 g  in 100 g
JOJOBA OIL (UNII: 724GKU717M) 8.97 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59958-240-0130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/11/2015
Labeler - Owen Biosciences, Inc. (790003045)
Establishment
NameAddressID/FEIBusiness Operations
Owen Biosciences, Inc.790003045manufacture(59958-240)

Revised: 1/2023
Document Id: f2680582-45d8-5d46-e053-2a95a90a0973
Set id: 02d46d44-2476-4f96-9c72-783c392317de
Version: 4
Effective Time: 20230116
 
Owen Biosciences, Inc.