Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Custom Analytics LLC
Brent Loftis, D.O., Inc., A California Medical Corporation
144949372
Fragrance Manufacturing INC
Brent Loftis, D.O., Inc., A California Medical Corporation
793406000
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SPF Lip
Product Details
NDC Product Code
85334-212Application Number
M020Marketing Category
OTC Monograph Drug (C200263)Route of Administration
TOPICALEffective Date
May 20, 2025ALUMINAInactive
Code: LMI26O6933Class: IACT
ALUMINUM HYDROXIDEInactive
Code: 5QB0T2IUN0Class: IACT
CERESINInactive
Code: Q1LS2UJO3AClass: IACT
Titanium dioxideActive
Code: 15FIX9V2JPClass: ACTIBQuantity: 40 mg in 1 g
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
ASCORBYL PALMITATEInactive
Code: QN83US2B0NClass: IACT
CETYL DIMETHYLBUTYL ETHERInactive
Code: 7LAB1GXG9GClass: IACT
CITRIC ACIDInactive
Code: 2968PHW8QPClass: IACT
DIPROPYLENE GLYCOL CAPRATE/CAPRYLATE DIESTERInactive
Code: R6G12EY23XClass: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0FClass: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0Class: IACT
PEG/PPG-15/15 DIMETHICONEInactive
Code: 184IZ28A2GClass: IACT
Zinc oxideActive
Code: SOI2LOH54ZClass: ACTIBQuantity: 55 mg in 1 g
CETEARYL ISONONANOATEInactive
Code: P5O01U99NIClass: IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAXInactive
Code: 42DG15CHXVClass: IACT
ALUMINUM STEARATEInactive
Code: U6XF9NP8HMClass: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQClass: IACT
ETHYLHEXYL PALMITATEInactive
Code: 2865993309Class: IACT
CI 77491Inactive
Code: 1K09F3G675Class: IACT
CI 77492Inactive
Code: EX438O2MRTClass: IACT
CI 77499Inactive
Code: XM0M87F357Class: IACT
SOYBEAN LECITHINInactive
Code: 1DI56QDM62Class: IACT
POLYGLYCERYL-3 DIISOSTEARATEInactive
Code: 46P231IQV8Class: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65APClass: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8Class: IACT
HEXYLDECYL LAURATEInactive
Code: 0V595C1P6MClass: IACT
ZINGIBER OFFICINALE (GINGER) ROOT OILInactive
Code: SAS9Z1SVUKClass: IACT
HEXYLDECANOLInactive
Code: 151Z7P1317Class: IACT
PEG-8Inactive
Code: B697894SGQClass: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
