MedPath
FDA Approval

Tinted Mineral Sunscreen

April 9, 2025

HUMAN OTC DRUG LABEL

Zinc oxide(38 mg in 1 g)
Titanium dioxide(80 mg in 1 g)

Manufacturing Establishments (2)

Fragrance Manufacturing Inc.

Rhonda J Pomerantz MD PLLC

793406000

Custom Analytics LLC

Rhonda J Pomerantz MD PLLC

144949372

Products (1)

Tinted Mineral Sunscreen

85327-203

M020

OTC Monograph Drug (C200263)

TOPICAL

April 9, 2025

DIMETHICONE CROSSPOLYMERInactive
Code: UF7620L1W6Class: IACT
CI 77492Inactive
Code: EX438O2MRTClass: IACT
Code: SOI2LOH54ZClass: ACTIBQuantity: 38 mg in 1 g
ALUMINAInactive
Code: LMI26O6933Class: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BAClass: IACT
PEG-10 DIMETHICONE (600 CST)Inactive
Code: 8PR7V1SVM0Class: IACT
Code: 15FIX9V2JPClass: ACTIBQuantity: 80 mg in 1 g
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0RClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
DIMETHICONOL (2000 CST)Inactive
Code: T74O12AN6YClass: IACT
CI 77491Inactive
Code: 1K09F3G675Class: IACT
LAURYL PEG/PPG-18/18 METHICONEInactive
Code: ZJ5S27D9NXClass: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5Class: IACT
HYDROGEN DIMETHICONE (20 CST)Inactive
Code: 12Z59IF64NClass: IACT
CI 77499Inactive
Code: XM0M87F357Class: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZClass: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
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