MedPath
FDA Approval

tinted mineral sunscreen

May 23, 2025

HUMAN OTC DRUG LABEL

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

Manufacturing Establishments (2)

Custom Analytics LLC

Skin & Bare It LLC

144949372

Fragrance Manufacturing INC

Skin & Bare It LLC

793406000

Products (1)

tinted mineral sunscreen

85425-203

M020

OTC Monograph Drug (C200263)

TOPICAL

May 23, 2025

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label


INDICATIONS & USAGE SECTION

DOSAGE & ADMINISTRATION SECTION


WARNINGS SECTION


OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


OTHER SAFETY INFORMATION

INACTIVE INGREDIENT SECTION


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