FDA.reportPublic FDA data

NDC 58443-0610 - Australian Gold Broad Spectrum SPF 4

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
58443-0610
Package NDCs from labels
58443-0610-4
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 Spray Oil Sunscreen Broad Spectrum SPF 4Prime 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 79 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: 6UYK2W1W1E
Sun Bum 70 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC39fb5e66-5172-3b83-e063-6394a90aab2d2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum Face Cream 50 Premium SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3c57fcf7-7816-8197-e063-6394a90af80a2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
Sun Bum 50 Premium Moisturizing Sunscreen Roll-OnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c58c9c7-ca9e-d012-e063-6394a90a5aa92025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a003d82-90bd-f541-e063-6394a90ac9062025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a00e4fb-6bf2-4c44-e063-6294a90a61bf2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a0f99df-e6c0-71d9-e063-6294a90a4c9e2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum Kids 50 Clear Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a147fe1-0dda-5433-e063-6394a90a1a592025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum 15 Premium Sunscreen BrowningAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c5b0db8-f05a-2b5c-e063-6294a90ae79b2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aaf7d28-b306-b416-e063-6294a90a021e2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - BonfireHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3a3b3b4a-148c-1dc5-e063-6394a90a7bdb2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude BeachHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3ac48eef-f651-af96-e063-6294a90a501e2025-08-14WarningsExact identifier
unii: 5A68WGF6WM
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NV6a398dad-2fb9-4cdb-86c5-2a392b88f29b2025-08-13WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c414e9b-6c3e-2c8d-e063-6394a90af4a62025-08-13WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c49c623-47c6-4dc9-e063-6294a90a00962025-08-13WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Men scented sunscreen SPF 50 woodsman SLAMAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Slam Lotion04c28d41-b4b7-41d3-85e0-4afca7bca3e62025-08-12WarningsExact identifier
unii: G63QQF2NOX
Men scented sunscreen SPF 50 beachman SLAMAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Slam Lotionfec77941-caae-41d2-bfcc-51f222ba29532025-08-12WarningsExact identifier
unii: G63QQF2NOX
Coola Anti-Aging Hand Cream SunscreenAVOBENZONE, OCTOCRYLENE, OCTISALATECOOLA LLC3c2fbf10-d68e-c601-e063-6294a90a09a32025-08-12WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
unii: 5A68WGF6WM
Gyntima Probiotica ForteSAGE, TEA TREE OIL, FOLIC ACID, LACTIC ACIDFytofontana LLC3c318c24-cc68-5589-e063-6394a90a8d802025-08-12WarningsExact identifier
unii: VIF565UC2G

Reported adverse events (FAERS/openFDA)#

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