EltaMD UV Clear SPF46
EltaMD UV Clear SPF46
Approved
Approval ID
60438ec5-0b1f-45fd-8ce4-debfdbdc6721
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
CP Skin Health Group, Inc.
DUNS: 611921669
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc oxide and Octinoxate sunscreen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72043-2500
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc oxide and Octinoxate sunscreen
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (16)
ZINC OXIDEActive
Quantity: 90 g in 1000 g
Code: SOI2LOH54Z
Classification: ACTIM
IODOPROPYNYL BUTYLCARBAMATEInactive
Code: 603P14DHEB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
OCTINOXATEActive
Quantity: 75 g in 1000 g
Code: 4Y5P7MUD51
Classification: ACTIB
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
CYCLOMETHICONE 5Inactive
Code: 0THT5PCI0R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
OCTYLDODECYL BENZOATEInactive
Code: R04N7AS5EA
Classification: IACT
OLETH-3 PHOSPHATEInactive
Code: 8Q0Z18J1VL
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)Inactive
Code: 86FQE96TZ4
Classification: IACT
POLYISOBUTYLENE (1000 MW)Inactive
Code: 5XB3A63Y52
Classification: IACT