MedPath

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

NDC Product Code85575-202
Application NumberM020
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
Generic NameTitanium Dioxide, Zinc Oxide

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

Package Label

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

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non-tinted sheer matte mineral - FDA Drug Approval Details