Luminous Tinted Moisturizing
Approved
Approval ID
35a8ae26-82eb-e4ca-e063-6394a90a0022
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 21, 2025
Manufacturers
FDA
SKIN BOSS L.L.C.
DUNS: 106879079
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code85503-204
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification
INGREDIENTS (32)
DIMETHICONE CROSSPOLYMERInactive
Code: UF7620L1W6
Classification: IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)Inactive
Code: 9E4CO0W6C5
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYGLYCERYL-4 ISOSTEARATEInactive
Code: 820DPX33S7
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
DIMETHICONOL (2000 CST)Inactive
Code: T74O12AN6Y
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
TRIETHOXYCAPRYLYLSILANEInactive
Code: LDC331P08E
Classification: IACT
ZINC OXIDEActive
Quantity: 200 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
BISMUTH OXYCHLORIDEInactive
Code: 4ZR792I587
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)Inactive
Code: 8INO2K35FA
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CAPRYLHYDROXAMIC ACIDInactive
Code: UPY805K99W
Classification: IACT
HYDROGEN DIMETHICONE (20 CST)Inactive
Code: 12Z59IF64N
Classification: IACT
PEG-30 DIPOLYHYDROXYSTEARATEInactive
Code: 9713Q0S7FO
Classification: IACT
CYCLOHEXASILOXANEInactive
Code: XHK3U310BA
Classification: IACT
CI 77499Inactive
Code: XM0M87F357
Classification: IACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)Inactive
Code: R327X197HY
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CI 77491Inactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE WAXInactive
Code: XOF597Q3KY
Classification: IACT
CYCLOPENTASILOXANEInactive
Code: 0THT5PCI0R
Classification: IACT
CI 77492Inactive
Code: EX438O2MRT
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
PEG-10 DIMETHICONE (600 CST)Inactive
Code: 8PR7V1SVM0
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 2/12/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 2/12/2024
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 2/12/2024
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 2/12/2024
WARNINGS SECTION
LOINC: 34071-1Updated: 2/12/2024
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 2/12/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 2/12/2024
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 2/12/2024
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 2/12/2024