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 78 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e4dbfd77-0eec-4d1a-94d6-4daca096d8c7 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 72569958-cd7d-4d52-add4-2b13706e1b1e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 0f5aa600-4168-419b-95d7-569764b5f0b9 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 2WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior e5ab0cd9-ae7f-4558-b5ab-e0b582677224 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior b9fa3bb9-12ec-40d8-b433-a96d9d00cc90 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f7b2e348-2c7f-4ff5-8ab0-a3475c9d1f26 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 69924eb8-a8ca-4ea0-b087-c865a6a1313f 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool Fosy OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 5cafac21-fb2d-4d63-a7fe-01bf53b941e8 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior bfc27e8d-e59b-46f7-aec9-2a96a00a7c1c 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 8fd56c86-ef37-4f31-87d1-6283a19c8424 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C Cool OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 91b62ba7-2deb-47e6-b9af-25bb459b4d75 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 6eec7554-38ed-48d4-916d-ab3660fbf703 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 939e6d5c-3dd7-4b01-af18-697dc4ba2d99 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 7149784b-3548-4643-abf6-58fde237bb98 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N Neutral OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 061181d8-5387-4541-a7d7-426cba5997a0 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm Olive OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f6ad554a-4795-4149-b066-c53a0989470e 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W Warm OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior 58efeaaf-d3c6-44e9-b60f-8f22f5bb1d33 2026-01-16 Warnings Exact identifier application number: M020 Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm Peach OCTISALATE, TITANIUM DIOXIDE Parfums Christian Dior f6b4a90b-5905-4f62-9e35-f2b1dda8dddd 2026-01-16 Warnings Exact identifier application number: M020 Poolside Frostbite Sunscreen Watermelon SPF 15 Scented Lip Gloss HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE I World LLC 42c8fd50-73c6-480b-9d7e-31157e586929 2026-01-16 Warnings Exact identifier application number: M020 HYDRA VIZOR HUEZ TINTED MOISTURIZER BROAD SPECTRUM SPF 30 ZINC OXIDE KENDO HOLDINGS INC. 18fb7472-746f-339a-e063-6294a90a267d 2026-01-16 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