EltaMD UV AOX Elements
UV AOX Elements Tinted
Approved
Approval ID
d01756c0-1f82-4e08-b956-8000ecaddfd1
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 1, 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, titanium dioxide sunscreen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72043-2522
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
zinc oxide, titanium dioxide sunscreen
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (29)
ZINC OXIDEActive
Quantity: 135.1 g in 1000 g
Code: SOI2LOH54Z
Classification: ACTIM
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CETYL DIMETHICONE 45Inactive
Code: IK315POC44
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 44.3 g in 1000 g
Code: 15FIX9V2JP
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
CARNOSINEInactive
Code: 8HO6PVN24W
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEInactive
Code: 25G622K2RA
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
BISABOLOLInactive
Code: 24WE03BX2T
Classification: IACT
ZINGIBER OFFICINALE (GINGER) ROOT OILInactive
Code: SAS9Z1SVUK
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
CANOLA OILInactive
Code: 331KBJ17RK
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMERInactive
Code: 21AS8B1BSS
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-Inactive
Code: WR1WPI7EW8
Classification: IACT
ALUMINAInactive
Code: LMI26O6933
Classification: IACT
HYDROGEN DIMETHICONE (45 CST)Inactive
Code: L2AFM6S5VW
Classification: IACT
DIPROPYLENE GLYCOLInactive
Code: E107L85C40
Classification: IACT