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 54 of 278 · 5,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OatmealDIMETHICONEBetter Living Brands, LLCd28c5a60-0597-424f-bf7f-08dca39b22f52026-02-23Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Allergy KidsURTICA DIOICA LEAF, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND ALTHAEA OFFICINALIS ROOTForces of Nature4886109c-dd7d-40c0-911f-5f12343d8e632026-02-20WarningsExact identifier
unii: 451W47IQ8X
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: 451W47IQ8X
Back Pain Pain ManagementARNICA MONTANA, HORSE CHESTNUT, HYPERICUM PERFORATUM, RUTA GRAVEOLENS WHOLE, AND SODIUM CHLORIDEForces of Naturebf089347-f334-4d6d-ab58-cf7f0b16810f2026-02-20WarningsExact identifier
unii: 451W47IQ8X
daily moisturizerAVBENZONE, OCTISALATE, OCTOCRYLENEMeijer, Inc.6d301146-46e0-445c-b14e-3ec8ce76cb452026-02-19Warnings, Adverse reactionsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
DimethiconeDIMETHICONEMeijer, Inc.75b91b97-ea84-4c4d-9e58-5a9ff27a778c2026-02-19Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDAILY MOISTURIZINGMeijer, Inc.44949b46-70f2-4e52-adba-a8455da614eb2026-02-19Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.e9f4a2bb-d21e-4b38-9a37-23c23c8ad8572026-02-19Warnings, Adverse reactionsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut ScentAVOBENZONE, OCTISALATE, OCTOCRYLENEInk-eeze3f759bec-4e33-46fa-a800-fa3a17d63df92026-02-19WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
SHISEIDO ESSENTIAL ENERGY HYDRATING DAYHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION8b88039a-09fe-458b-b80f-49cde49b65952026-02-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED nAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf3729d0b-e601-48bb-9907-1d6e3ab319962026-02-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Luminesce Daily Moisturizing ComplexAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEVelovita Inc.4b0c2213-8667-be6f-e063-6394a90a5e862026-02-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Daily MoisturizingDIMETHICONEValu Merchandisers Company0cccadd7-11f3-5d1f-e063-6294a90a55c42026-02-16Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companye168f8e8-22d0-4a60-b9f9-dec9d0fab3f12026-02-16Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Companycfc3b202-6511-450a-b3c1-2d8e8ebc070d2026-02-16Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATEValu Merchandisers Company5a8af0ea-b31c-456a-bc23-31e2473ca75a2026-02-16Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
RHODODIUMACTEA RACEMOSA, APIS MELL, CALC CARB, GRAPHITES, IODIUM, NATRUM MUR, PULSATILLA, RHODODENDRONBM Private Limited3b3bcba2-6f9e-cd94-e063-6394a90a77012026-02-15WarningsExact identifier
unii: 451W47IQ8X
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab542aa-bd05-ba7a-e063-6294a90ae5842026-02-13Warnings, Adverse reactionsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
DimethiconeDIMETHICONETopco Associates LLCf37f17f7-f084-4b74-8361-178d2315a4762026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O
Daily MoisturizingDIMETHICONETopco Associates LLC47e54eee-70e0-4bfa-ae77-d61a6560a9e12026-02-13Warnings, Adverse reactionsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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