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 44 of 278 · 5,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
unii: 92RU3N3Y1O
Sunscreen SPF 50AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain9647b817-653f-45e5-b71a-ee9ad82e84eb2026-03-18WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
Kids Sunscreen SPF 50AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain34891204-3485-44ac-aaf1-80d57593128c2026-03-18WarningsExact identifier
unii: G63QQF2NOX
unii: 4X49Y0596W
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERBryant Ranch Prepackf9f15374-4809-4b96-8a07-3c2f1011d1102026-03-18WarningsExact identifier
unii: 9E8X80D2L0
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 5A68WGF6WM
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
SPF 50 Chemical Fragrance free SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionadce05cf-da63-49bc-bada-78665e2b7ce82026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
SPF 50 Chemical Gentleman SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionde261b15-395e-4e9c-beea-24bea0b695a82026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Avobenzone, Homosalate, Octisalate, OctocryleneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4d3a36b9-7d63-01ac-e063-6294a90af4fb2026-03-17Warnings, Adverse reactionsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3a460b-1b98-2906-e063-6294a90a36692026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.42477582-3ffa-4e51-a29b-86da07b143822026-03-17WarningsExact identifier
unii: 92RU3N3Y1O
SunscreenBROAD SPECTRUM SPF 30SKNVCARE, LLC4d3ad051-3729-06fd-e063-6394a90ad0fe2026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
MediChoice BarrierDIMETHICONEO&M HALYARD, INC.115c2a2f-d68a-316a-e063-6394a90a27162026-03-17WarningsExact identifier
unii: 92RU3N3Y1O
Redneck SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERedneck Sunscreen LLC4d3cc62d-9e2f-c929-e063-6294a90a913a2026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
SOME BY MI TRUECICA AQUA CALMING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPERENNEBELL Co., Ltd.4d42d5aa-d12e-1086-e063-6294a90a12df2026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
GOODAL HEARTLEAF SOOTHING QUICK SLIDING SUNSCREEN StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECLIO COSMETICS Co., Ltd.bce6008b-3dab-44e4-9a07-d996bf652d072026-03-17WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
unii: 4X49Y0596W
MIZON SNAIL REPAIR INTENSIVE BB No. 23ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d206947-1e89-7ef1-e063-6394a90a7d072026-03-16WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W
MIZON SNAIL REPAIR INTENSIVE BB No. 25ZINC OXIDE, OCTISALATE, OCTOCRYLENEPFD Co.,Ltd.4d207687-b58f-916d-e063-6394a90a737f2026-03-16WarningsExact identifier
unii: 5A68WGF6WM
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

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