illuminating mineral mousse

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Tri Pac, Inc.

Labeler

NEXTEX CORPORATION

DUNS Number

020844956

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

85575-210

Application Number

M020

Marketing Category

OTC Monograph Drug (C200263)

Route of Administration

TOPICAL

Effective Date

May 22, 2025

Ingredients

BISMUTH OXYCHLORIDEInactive

Code: 4ZR792I587Class: IACT

CELLULOSE GUMInactive

Code: K679OBS311Class: IACT

CETEARETH-20Inactive

Code: YRC528SWUYClass: IACT

CETEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACT

CITRIC ACIDInactive

Code: 2968PHW8QPClass: IACT

GLYCERETH-26Inactive

Code: NNE56F2N14Class: IACT

GLYCERYL STEARATEInactive

Code: 230OU9XXE4Class: IACT

CI 77492Inactive

Code: EX438O2MRTClass: IACT

ISODODECANEInactive

Code: A8289P68Y2Class: IACT

ISOHEXADECANEInactive

Code: 918X1OUF1EClass: IACT

MICAInactive

Code: V8A1AW0880Class: IACT

OCTYLDODECYL NEOPENTANOATEInactive

Code: X8725R883TClass: IACT

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive

Code: 8Z5ZAL5H3VClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

1,3,3,3-TETRAFLUOROPROPENE, (1E)-Inactive

Code: 5I2481UOO8Class: IACT

TRIETHOXYCAPRYLYLSILANEInactive

Code: LDC331P08EClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

POLYHYDROXYSTEARIC ACID (2300 MW)Inactive

Code: YXH47AOU0FClass: IACT

OCTYLDODECYL ERUCATEInactive

Code: D4N66T98C2Class: IACT

Zinc oxideActive

Code: SOI2LOH54ZClass: ACTIBQuantity: 100 mg in 1 g

BUTYLOCTYL SALICYLATEInactive

Code: 2EH13UN8D3Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

Titanium dioxideActive

Code: 15FIX9V2JPClass: ACTIBQuantity: 30 mg in 1 g

GLYCERINInactive

Code: PDC6A3C0OXClass: IACT

CAPRYLHYDROXAMIC ACIDInactive

Code: UPY805K99WClass: IACT

CAPRYLYL GLYCOLInactive

Code: 00YIU5438UClass: IACT

CI 77491Inactive

Code: 1K09F3G675Class: IACT

TRIACONTANYL PVPInactive

Code: N0SS3Q238DClass: IACT

CI 77499Inactive

Code: XM0M87F357Class: IACT

POLY(METHYL METHACRYLATE; 450000 MW)Inactive

Code: Z47NNT4J11Class: IACT

C12-15 ALKYL BENZOATEInactive

Code: A9EJ3J61HQClass: IACT

EDETATE DISODIUM ANHYDROUSInactive

Code: 8NLQ36F6MMClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

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illuminating mineral mousse

FDA Approval Summary

Manufacturing Establishments1

Products1