illuminating mineral mousse
Approved
Approval ID
35bb4d67-373f-f60c-e063-6394a90a974d
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 Code85575-210
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 (32)
BISMUTH OXYCHLORIDEInactive
Code: 4ZR792I587
Classification: IACT
CELLULOSE GUMInactive
Code: K679OBS311
Classification: IACT
CETEARETH-20Inactive
Code: YRC528SWUY
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERETH-26Inactive
Code: NNE56F2N14
Classification: IACT
GLYCERYL STEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CI 77492Inactive
Code: EX438O2MRT
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
ISOHEXADECANEInactive
Code: 918X1OUF1E
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3V
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
1,3,3,3-TETRAFLUOROPROPENE, (1E)-Inactive
Code: 5I2481UOO8
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
OCTYLDODECYL ERUCATEInactive
Code: D4N66T98C2
Classification: IACT
ZINC OXIDEActive
Quantity: 100 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
BUTYLOCTYL SALICYLATEInactive
Code: 2EH13UN8D3
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 30 mg in 1 g
Code: 15FIX9V2JP
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CAPRYLHYDROXAMIC ACIDInactive
Code: UPY805K99W
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
CI 77491Inactive
Code: 1K09F3G675
Classification: IACT
TRIACONTANYL PVPInactive
Code: N0SS3Q238D
Classification: IACT
CI 77499Inactive
Code: XM0M87F357
Classification: IACT
POLY(METHYL METHACRYLATE; 450000 MW)Inactive
Code: Z47NNT4J11
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 1/22/2020
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 1/22/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 1/22/2020
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/22/2020
WARNINGS SECTION
LOINC: 34071-1Updated: 1/22/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 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