FDA.reportPublic FDA data

NDC 58443-0643 - Australian Gold SPF 15

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
58443-0643
Package NDCs from labels
58443-0643-4
Manufacturer
Prime Enterprises, Inc.
Effective date
2023-10-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Australian Gold Instant Bronzer Spray Gel Sunscreen SPF 15Prime Enterprises, Inc.2023-10-31HUMAN 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 55 of 278 · 5,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDETopco Associates LLC48fb9a3c-c058-ce71-e063-6294a90aaf1e2026-02-13Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
TEENY TUMMY Gas Relief DropsSIMETHICONEALTANTIC BIOLOGICAS CORP.05eadb73-4468-4dae-a67b-133d893feed22026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
unii: 92RU3N3Y1O
BM CalendulaCALENDULA OFFICINALISBM Private Limited388ca53f-be13-b8d1-e063-6294a90a12342026-02-12WarningsExact identifier
unii: ZY81Z83H0X
Ambi Even and Clear Facial MoisturizerHOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 3%, AVOBENZONE 3%73453-112469440e9-bf47-bebd-e063-6294a90acca22026-02-12WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
WowDay Hemorrhoid and Fissure CreamHEMORRHOID AND FISSURE CREAMWowDay LLC47ba86ad-240a-e733-e063-6394a90a24e32026-02-12WarningsExact identifier
unii: PDC6A3C0OX
iShanCare Folliculitis CleansingISHANCARE FOLLICULITIS CLEANSINGShenzhen Ishan Technology Co., Ltd3ca2ffbc-1cdc-0ebd-e063-6394a90af47a2026-02-12WarningsExact identifier
unii: VIF565UC2G
HOMWIS Eczema ReliefECZEMA RELIEF SOAPShenzhen Ishan Technology Co., Ltd3ca0d0f2-55cd-09f2-e063-6294a90ac56f2026-02-12WarningsExact identifier
unii: VIF565UC2G
Eva Claire Natural Professional SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEEva Claire Cosmetics Co., Ltd.4a870452-cac2-4d2c-e063-6294a90abb072026-02-11WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Ganrek SUNSCREEN SPRAYER Broad Spectrum SPF 50SUNSCREEN SPF 50Guangzhou Meixi Biotechnology Co., Ltd.4a3adb04-5e3a-80bf-e063-6294a90a60472026-02-10WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Sugargirl Glow Up Body Illuminator Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC364d4d87-2d3e-4515-a3f2-1506d871699d2026-02-10WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Sugargirl Sunshine Body Illuminator Glowy Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea801e6c-44f9-4ec9-9022-5b637baf7d592026-02-10WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Poolside Golden Hour SPF 15 Sunscreen LipHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC7d0f8319-f0fa-4ea7-bb66-427c5a78145a2026-02-10WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Walgreens ULTRA FINE MOISTURIZING SALINE MISTNASAL MISTWALGREEN COMPANY48fef521-1b1d-d0d5-e063-6394a90ac7b12026-02-10WarningsExact identifier
unii: 451W47IQ8X
Walgreens SALINE MISTNASAL MISTWALGREEN COMPANY44815675-cc1d-a582-e063-6394a90ae8f62026-02-10WarningsExact identifier
unii: 451W47IQ8X
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
unii: PDC6A3C0OX
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBENOW BEAUTY INC32bfb17c-5535-c016-e063-6394a90a18142026-02-09WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4a6b69ed-2739-d22a-e063-6294a90a1e522026-02-09WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
SUNPLUS LIP LIFESUNSCREENI. Shay Cosmetics26d28286-e812-0fb3-e063-6394a90a338d2026-02-09WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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