Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Custom Analytics LLC
CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC
144949372
Fragrance Manufacturing INC
CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC
793406000
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tinted Mineral Sunscreen
Product Details
NDC Product Code
85493-203Application Number
M020Marketing Category
OTC Monograph Drug (C200263)Route of Administration
TOPICALEffective Date
May 22, 2025Zinc oxideActive
Code: SOI2LOH54ZClass: ACTIBQuantity: 38 mg in 1 g
Titanium dioxideActive
Code: 15FIX9V2JPClass: ACTIBQuantity: 80 mg in 1 g
CYCLOHEXASILOXANEInactive
Code: XHK3U310BAClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
DIMETHICONOL (2000 CST)Inactive
Code: T74O12AN6YClass: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5Class: IACT
CI 77491Inactive
Code: 1K09F3G675Class: IACT
PEG-10 DIMETHICONE (600 CST)Inactive
Code: 8PR7V1SVM0Class: IACT
HYDROGEN DIMETHICONE (20 CST)Inactive
Code: 12Z59IF64NClass: IACT
ALUMINAInactive
Code: LMI26O6933Class: IACT
CI 77492Inactive
Code: EX438O2MRTClass: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZClass: IACT
LAURYL PEG/PPG-18/18 METHICONEInactive
Code: ZJ5S27D9NXClass: IACT
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0RClass: IACT
DIMETHICONE CROSSPOLYMERInactive
Code: UF7620L1W6Class: IACT
CI 77499Inactive
Code: XM0M87F357Class: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
