Home NDC 58443-0589 Austalian Gold
Product NDC 58443-0589
11-digit product format 584430589
Labeler code 58443
Product ID 58443-0589_ed9e76ff-2bd8-172c-e053-2995a90a198a
Type HUMAN OTC DRUG
Nonproprietary name Octisalate, Avobenzone, Octocrylene, Homosalate
Dosage form SPRAY
Route TOPICAL
Labeler Prime Enterprises Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2019-10-30
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30 g/mL; g/mL; g/mL; g/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58443-0589-4 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58443-0589-4 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58443-0589-4 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58443-0589-4 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58443-0589-4 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58443-0589-4 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58443-0589-4 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58443-0589-4 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58443-0589-4 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58443-0589-4 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58443-0589-4 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58443-0589-4 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58443-0589-4 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58443-0589-4 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58443-0589-4 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58443-0589-4 Austalian GoldBroad Spectrum SPF 30 Sunscreen 237 mL in 1 BOTTLE, SPRAY SPRAY 237 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0589 AUSTALIAN GOLD BROAD SPECTRUM SPF 30 SUNSCREEN (OCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE) SPRAY [PRIME ENTERPRISES INC.] 1 Legacy NDC, 1 package rows 20221119_ed9e76ff-2bd7-172c-e053-2995a90a198a.zip
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 82 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Blue Lizard Kids SPF 50 ZINC OXIDE Crown Laboratories 9983563c-1e63-0748-e053-2a95a90a971e 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Baby SPF 50 ZINC OXIDE Crown Laboratories 9948f5b8-43bd-1c99-e053-2a95a90a6121 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sheer SPF 50 Sunscreen ZINC OXIDE Crown Laboratories 3368f1cb-c341-e886-e063-6394a90a9b7c 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sport SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 2f3844d8-0367-aad9-e063-6294a90a1fce 2026-01-12 Warnings Exact identifier application number: M020 Blue Lizard Sheer Face SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Crown Laboratories 30cd79da-2f25-a42a-e063-6394a90a8332 2026-01-12 Warnings Exact identifier application number: M020 ACCOJE PROTECTIVE AIR-FIT MINERAL SUNSCREEN TITAMIUN DIOXIDE, ZINC OXIDE UCL Co., Ltd. 4837b4f6-ada9-801a-e063-6294a90a8547 2026-01-12 Warnings Exact identifier application number: M020 Intellishade Original SPF 45 OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE Revision, LLC e213a681-eb22-69c0-e053-2995a90a899e 2026-01-12 Warnings Exact identifier application number: M020 GINZING SPF 40 ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 SHEER TINT RELEASE HOMOSALATE,OCTINOXATE,OCTISALATE, AND ZINC OXIDE ORIGINS NATURAL RESOURCES INC. 48393640-4b97-04de-e063-6294a90aa6a6 2026-01-12 Warnings Exact identifier application number: M020 Hale and Hush Broad Spectrum SPF 30 SPF 30 ZINC OXIDE Eclectic Solutions LLC 0530904f-b02c-d8cf-e063-6294a90aa5a7 2026-01-12 Warnings Exact identifier application number: M020 Minori Daily Mineral Face Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Minori Inc. 1d4e2654-1638-0d01-e063-6394a90af303 2026-01-12 Warnings Exact identifier application number: M020 LUXURY BODY RITUAL HYDRATING SPF 30 ZINC OXIDE JANE STREET LLC 15e9d688-f226-1a19-e063-6394a90ab906 2026-01-12 Warnings Exact identifier application number: M020 BROAD SPECTRUM SPF50 SPF 50 AVOBENZONE, HOMOSALATE OCTISALATE, NAKED SUNDAYS PTY LTD 0426b1e9-063b-c1e6-e063-6294a90a2554 2026-01-11 Warnings Exact identifier application number: M020 SPF30 MINERAL SUNSCREEN MOUSSE ZINC OXIDE Aopline Biotechnology (Guangzhou) Co., Ltd. 48031a0f-c2ed-5424-e063-6294a90ad0ff 2026-01-10 Warnings Exact identifier application number: M020 SPF 30 MINERAL WHIPPED CREAMS SHIMMER ZINC OXIDE Aopline Biotechnology (Guangzhou) Co., Ltd. 48037a05-722e-4231-e063-6294a90ac51f 2026-01-10 Warnings Exact identifier application number: M020 ODLUMIVIE Tinted Mineral Sunscreen ZINC OXIDE,TITANIUM DIOXIDE Guangzhou Meijiao Medical Biotechnology Co., Ltd. 480d6e65-f6dc-d2a5-e063-6294a90a24a1 2026-01-10 Warnings Exact identifier application number: M020 Cloud Brush On Sunscreen Clear Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE FUTURE 8 LLC 9922f132-f6a5-41ca-847a-936b20bf1716 2026-01-09 Warnings Exact identifier application number: M020 Sunscreen Lotion118mL ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% Foshan Sugar Max Cosmetics CO.,Ltd 46355437-4068-9d03-e063-6394a90ae52c 2026-01-09 Warnings Exact identifier application number: M020 ST MORIZ SUNCARE FACE SUNSCREEN SPF30 SUNCARE FACE SUNSCREEN SPF30 Aopline Biotechnology (Guangzhou) Co., Ltd. 47f26af6-4d02-3506-e063-6294a90a0fe6 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. Tuna Sun 6 SPF Tan and Care Carrot OCTINOXATE Farmasi US LLC 67de9257-70f3-4444-a4a2-a8d7425fcc0e 2026-01-09 Warnings Exact identifier application number: M020 Dr. C. Tuna Sunscreen SPF30 Broad Spectrum AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE Farmasi US LLC d9197dce-20a3-4d10-807c-ec84ab902165 2026-01-09 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0589-4 58443058904 237 mL in 1 BOTTLE, SPRAY (58443-0589-4) 237 ml 2019-10-30 0000-00-00 No No Current