FDA.reportPublic FDA data

NDC 58443-0609 - Australian Gold SPF 30

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
58443-0609
Package NDCs from labels
58443-0609-4
Manufacturer
Prime Enterprises, Inc.
Effective date
2023-03-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Australian Gold SPF 30 - Prime Enterprises, Inc.Prime Enterprises, Inc.2023-03-01HUMAN 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 115 of 246 · 4,901 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
ERBORIAN CC RED CORRECTERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAMKolmask Co., Ld.09ca2d4b-e0c2-9961-e063-6394a90aa82e2025-09-18Exact identifier
unii: 4X49Y0596W
ELROEL Pang Pang Sun Cushion PlusZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEMONOGLOT HOLDINGS Inc.5ffaad65-f0b2-416a-b0a3-b92e880641e42025-09-18WarningsExact identifier
unii: 4X49Y0596W
e.l.f. Camo CC Cream SPF 30 Fair 125 CHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.407f9c0d-31c6-f5bb-e063-6394a90a4db42025-09-18WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1630feee-7e0d-c6f4-e063-6294a90a7b1c2025-09-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
ONE SIZE ON TIL DAWNONE SIZE ON TIL DAWNPogi Beauty LLC3f05d90b-9274-4d21-e063-6294a90a84852025-09-17WarningsExact identifier
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 WHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEe.l.f. Cosmetics, Inc.3fa7ef54-2c4d-9883-e063-6294a90a8d882025-09-17WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKLEIN TOOLS, INC.3edcc26a-d960-3fa8-e063-6394a90ab7032025-09-15WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Klein Tools Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEKLEIN TOOLS, INC.3ede5e54-4c9f-02f7-e063-6294a90a9df62025-09-15WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
REFRESH OPTIVE DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
unii: PDC6A3C0OX
Refresh RelievaCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.6b984fa2-4187-45ef-b7d3-15e720abc6672025-09-15WarningsExact identifier
unii: PDC6A3C0OX
I.C. Industrial SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incb89d687a-7b36-4643-9817-765d4710ca602025-09-15WarningsExact identifier
unii: 4X49Y0596W
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC97795f0e-d867-4e17-b7c9-ede08e7df70c2025-09-12WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
Oasis Tears PF Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.640f95f4-c2e8-48ad-ad40-f76bbaddb0dc2025-09-12WarningsExact identifier
unii: PDC6A3C0OX
Beach Club Mineral SunscreenZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATER & R Lotion, Incd9aae241-229e-4123-abe9-99f74f5ab0b32025-09-12WarningsExact identifier
unii: 4X49Y0596W
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Basin Sun Stick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.3e78026e-0a6a-9e67-e063-6294a90a1bca2025-09-10WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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