Tinted Mineral Sunscreen
Tinted Mineral Sunscreen SPF 50
Approved
Approval ID
13e5085f-df2b-46b2-b063-e58ce4379905
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
Topiderm, Inc.
DUNS: 049121643
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc Oxide and Titanium Dioxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51326-123
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide and Titanium Dioxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (26)
CETETH-20 PHOSPHATEInactive
Code: 921FTA1500
Classification: IACT
TRIETHOXYSILANEInactive
Code: 8T460WDH89
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ZINC OXIDEActive
Quantity: 110 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
TITANIUM DIOXIDEActive
Quantity: 75 mg in 1 g
Code: 15FIX9V2JP
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
METHYL TRIMETHICONEInactive
Code: S73ZQI0GXM
Classification: IACT
ISONONYL ISONONANOATEInactive
Code: S4V5BS6GCX
Classification: IACT
OLETH-3 PHOSPHATEInactive
Code: 8Q0Z18J1VL
Classification: IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEInactive
Code: TYP81E471F
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
OCTYLDODECYL NEOPENTANOATEInactive
Code: X8725R883T
Classification: IACT
VINYLPYRROLIDONE/EICOSENE COPOLYMERInactive
Code: 035MV9S1C3
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)Inactive
Code: 1DXE3F3OZX
Classification: IACT
DEXPANTHENOLInactive
Code: 1O6C93RI7Z
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
DIHEXADECYL PHOSPHATEInactive
Code: 2V6E5WN99N
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT