FDA.reportPublic FDA data

NDC 58443-0622 - Austalian Gold Broad Spectrum SPF 50 Sunscreen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58443-0622
Package NDCs from labels
58443-0622-4
Manufacturer
Prime Enterprises Inc.
Effective date
2023-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Australian Gold Botanical Sunscreen Tinted Face 50 (non-Kakadu)Prime Enterprises Inc.2023-07-14HUMAN OTC DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 49 of 297 · 5,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
Diaper RashZINC OXIDEValu Merchandisers Companye5465ddd-e38c-44a4-bb9b-3edbc636576d2026-02-16Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Diaper RashZINC OXIDEUnited Natural Foods, Inc. dba UNFI014d0028-486e-4f1c-a14f-8162e393ebca2026-02-16Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Sparms 100% Organic Face SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae6b187-142b-e4a6-e063-6294a90af3652026-02-15WarningsExact identifier
unii: SOI2LOH54Z
Lotus Harmony - Quinn Shield Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4ae73d23-1118-716c-e063-6394a90a68c72026-02-15WarningsExact identifier
unii: SOI2LOH54Z
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
Diaper RashZINC OXIDETopco Associates LLC8acb1b47-70ed-4aa2-a7c0-e807042affc72026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Beauty HydratingHOMOSALATE, ZINC OXIDETopco Associates LLC6e88ccc8-8576-4573-8a5b-28e64008a3492026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab759ae-0c1c-bddc-e063-6394a90a1d092026-02-13WarningsExact identifier
unii: SOI2LOH54Z
Wotnot Naturals Natural Zinc Sunscreen SPF 30ZINC OXIDEECOdirect Pty Ltd (Trading as Wotnot Naturals)4ab83b34-9376-d169-e063-6394a90a18cd2026-02-13WarningsExact identifier
unii: SOI2LOH54Z
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
BM Pimples CureBERBERIS AQUIFOLIUM, HYDROCOTYLE, KALI BROMATUM, ZINC OXIDEBM Private Limited388de556-9a81-aecc-e063-6394a90a1e172026-02-12WarningsExact identifier
unii: SOI2LOH54Z
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
MERC CORRALUMINA, BRYONIA, COLOCYNTHIS, CHINA OFF, LYCOPODIUM, THUJA OCC, NUX VOMBM Private Limited3b29d70d-f291-dad2-e063-6294a90a07f52026-02-12WarningsExact identifier
unii: LMI26O6933
Diaper RashZINC OXIDEWinCo Foods, LLC659cc8c7-6300-41c0-a684-c5fde7f2b1002026-02-12Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
Zinc OxideZINC OXIDEWalgreen Co.220f70e1-0802-4fe2-92d0-78dec557c9932026-02-12Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.