Powder
PUR 4-in-1 Pressed Mineral Makeup - PORCELAIN
Approved
Approval ID
08b7eeeb-09ae-ffe6-e063-6294a90aba90
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 7, 2025
Manufacturers
FDA
Oxygen Development LLC
DUNS: 137098492
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Titanium Dioxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61354-118
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Titanium Dioxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (11)
MEDIUM-CHAIN TRIGLYCERIDESInactive
Quantity: 8 mg in 100 mg
Code: C9H2L21V7U
Classification: IACT
MAGNESIUM SILICATEInactive
Quantity: 2 mg in 100 mg
Code: 9B9691B2N9
Classification: IACT
MANNITOLInactive
Quantity: 1.67 mg in 100 mg
Code: 3OWL53L36A
Classification: IACT
BORON NITRIDEInactive
Quantity: 8 mg in 100 mg
Code: 2U4T60A6YD
Classification: IACT
SILICON DIOXIDEInactive
Quantity: 0.5 mg in 100 mg
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Quantity: 1.89 mg in 100 mg
Code: H8AV0SQX4D
Classification: IACT
BISMUTH OXYCHLORIDEInactive
Quantity: 10 mg in 100 mg
Code: 4ZR792I587
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 10 mg in 100 mg
Code: 15FIX9V2JP
Classification: ACTIB
MICAInactive
Quantity: 53.09 mg in 100 mg
Code: V8A1AW0880
Classification: IACT
ZINC STEARATEInactive
Quantity: 2.8 mg in 100 mg
Code: H92E6QA4FV
Classification: IACT
FERRIC OXIDE REDActive
Quantity: 1.75 mg in 100 mg
Code: 1K09F3G675
Classification: ACTIB