non-tinted sheer matte mineral
Approved
Approval ID
35ba6cc9-0d49-6d0c-e063-6394a90ac7c3
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 22, 2025
Manufacturers
FDA
NEXTEX CORPORATION
DUNS: 006596095
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Titanium Dioxide, Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code85575-202
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Titanium Dioxide, Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEActive
Quantity: 80 mg in 1 g
Code: 15FIX9V2JP
Classification: ACTIB
ALUMINAInactive
Code: LMI26O6933
Classification: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BA
Classification: IACT
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
DIMETHICONE CROSSPOLYMERInactive
Code: UF7620L1W6
Classification: IACT
HYDROGEN DIMETHICONE (20 CST)Inactive
Code: 12Z59IF64N
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
DIMETHICONOL (2000 CST)Inactive
Code: T74O12AN6Y
Classification: IACT
LAURYL PEG/PPG-18/18 METHICONEInactive
Code: ZJ5S27D9NX
Classification: IACT
PEG-10 DIMETHICONE (600 CST)Inactive
Code: 8PR7V1SVM0
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
ZINC OXIDEActive
Quantity: 38 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 1/22/2020
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 1/22/2020
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 1/22/2020
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 1/22/2020
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 1/22/2020
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 1/22/2020
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/22/2020
WARNINGS SECTION
LOINC: 34071-1Updated: 1/22/2020
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 1/22/2020