SPF Lip
Approved
Approval ID
359297cd-10e2-6ddd-e063-6394a90a4aa0
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 20, 2025
Manufacturers
FDA
Brent Loftis, D.O., Inc., A California Medical Corporation
DUNS: 104222451
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Titanium Dioxide, Zinc Oxide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code85334-212
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Titanium Dioxide, Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification
INGREDIENTS (29)
ALUMINAInactive
Code: LMI26O6933
Classification: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0
Classification: IACT
CERESINInactive
Code: Q1LS2UJO3A
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 40 mg in 1 g
Code: 15FIX9V2JP
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
CETYL DIMETHYLBUTYL ETHERInactive
Code: 7LAB1GXG9G
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERInactive
Code: R6G12EY23X
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
PEG/PPG-15/15 DIMETHICONEInactive
Code: 184IZ28A2G
Classification: IACT
ZINC OXIDEActive
Quantity: 55 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB
CETEARYL ISONONANOATEInactive
Code: P5O01U99NI
Classification: IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAXInactive
Code: 42DG15CHXV
Classification: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HM
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309
Classification: IACT
CI 77491Inactive
Code: 1K09F3G675
Classification: IACT
CI 77492Inactive
Code: EX438O2MRT
Classification: IACT
CI 77499Inactive
Code: XM0M87F357
Classification: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62
Classification: IACT
POLYGLYCERYL-3 DIISOSTEARATEInactive
Code: 46P231IQV8
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
HEXYLDECYL LAURATEInactive
Code: 0V595C1P6M
Classification: IACT
ZINGIBER OFFICINALE (GINGER) ROOT OILInactive
Code: SAS9Z1SVUK
Classification: IACT
HEXYLDECANOLInactive
Code: 151Z7P1317
Classification: IACT
PEG-8Inactive
Code: B697894SGQ
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/19/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/19/2024
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 4/19/2024
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 4/19/2024
WARNINGS SECTION
LOINC: 34071-1Updated: 4/19/2024
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
LOINC: 50565-1Updated: 4/19/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/19/2024
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 4/19/2024
OTHER SAFETY INFORMATION
LOINC: 60561-8Updated: 4/19/2024