PROSKI SHIELD
Dimethicone skin protectant with vitamin A,D,E, zinc oxide & aloe Vera.
Approved
Approval ID
2c7768a6-5859-74ca-e063-6394a90a8ef3
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 18, 2025
Manufacturers
FDA
PHARMAMED USA INC
DUNS: 065607328
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dimethicone, Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code84289-408
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dimethicone, Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 18, 2025
FDA Product Classification
INGREDIENTS (19)
ZINC OXIDEActive
Quantity: 2 g in 100 g
Code: SOI2LOH54Z
Classification: ACTIB
WHITE PETROLATUMInactive
Code: B6E5W8RQJ4
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
ALPHA-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETETH-20Inactive
Code: I835H2IHHX
Classification: IACT
LAVENDER OILInactive
Code: ZBP1YXW0H8
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
DIMETHICONEActive
Quantity: 1.8 g in 100 g
Code: 92RU3N3Y1O
Classification: ACTIB
CHOLECALCIFEROLInactive
Code: 1C6V77QF41
Classification: IACT
VITAMIN A ACETATEInactive
Code: 3LE3D9D6OY
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
YELLOW 5Inactive
Code: I753WB2F1M
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT