Non - Tinted Mineral Sunscreen
Approved
Approval ID
35bacfcf-0254-aa0a-e063-6394a90a1475
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 22, 2025
Manufacturers
FDA
NEXTEX CORPORATION
DUNS: 006596095
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Zinc Oxide
PRODUCT DETAILS
NDC Product Code85575-205
Application NumberM020
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 22, 2025
Generic NameZinc Oxide
INGREDIENTS (27)
CAPRYLHYDROXAMIC ACIDInactive
Code: UPY805K99W
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)Inactive
Code: 8INO2K35FA
Classification: IACT
DIMETHICONE CROSSPOLYMERInactive
Code: UF7620L1W6
Classification: IACT
ZINC OXIDEActive
Quantity: 200 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
DIMETHICONOL (2000 CST)Inactive
Code: T74O12AN6Y
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PEG-10 DIMETHICONE (600 CST)Inactive
Code: 8PR7V1SVM0
Classification: IACT
PEG-30 DIPOLYHYDROXYSTEARATEInactive
Code: 9713Q0S7FO
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)Inactive
Code: R327X197HY
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BA
Classification: IACT
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0R
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
HYDROGEN DIMETHICONE (20 CST)Inactive
Code: 12Z59IF64N
Classification: IACT
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
POLYGLYCERYL-4 ISOSTEARATEInactive
Code: 820DPX33S7
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/22/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/22/2025
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/22/2025
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/22/2025
WARNINGS SECTION
LOINC: 34071-1Updated: 4/22/2025
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/22/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/22/2025
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/22/2025
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 4/22/2025