Home NDC 58443-0578-4 Australian Gold
Product NDC 58443-0578
Requested package NDC 58443-0578-4
11-digit product format 584430578
Labeler code 58443
Product ID 58443-0578_ed0ad891-74ed-513d-e053-2995a90af7af
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Prime Enterprises Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2017-10-02
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 29 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 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 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 58443-0578-4 Australian GoldInstant Brozer SPF 30 Sunscreen 125 mL in 1 BOTTLE SPRAY 125 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0578 AUSTRALIAN GOLD INSTANT BROZER SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME ENTERPRISES INC.] 2 Legacy NDC, 1 package rows 20221110_ecfbb53a-0f05-9dcc-e053-2a95a90afb66.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 1 of 361 · 7,213 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk SPF50 Grace And Fire USA Inc. 2735ab0f-5eec-04c5-e063-6394a90aa60e 2026-10-01 Warnings Exact identifier application number: M020 Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled SPF50 Grace And Fire USA Inc. 274a0544-6c71-4d91-e063-6394a90a2247 2026-10-01 Warnings Exact identifier application number: M020 TRILIPIDERM All-Body Moisture Retention SPF-30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE Trilipid Research Institute, LLC 7f34de0a-eeb3-4b71-9abd-53d03266d993 2026-09-10 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 6a43173f-41f9-4207-a0db-53bc8db6f4a4 2026-09-10 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC d69b4992-d7e6-4bd7-b144-0485e35818a6 2026-09-10 Warnings Exact identifier application number: M020 Hydra Finish SPF 15 HOMOSALATE, OCTINOXATE Guinot 4047e8ec-834a-41e6-a144-5649a7718de4 2026-09-10 Warnings Exact identifier application number: M020 HYDRA BEAUTE SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Guinot 806d1e18-a3fc-43df-a52a-a640902d0887 2026-09-10 Warnings Exact identifier application number: M020 Pur Confort SPF 15 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Guinot 2fe0656f-f924-48da-91bf-d6f3d98e8fd9 2026-09-10 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 51f3d6ca-3189-4380-9afb-4259ba878274 2026-09-10 Warnings Exact identifier application number: M020 Sun Logic Creme Solaire Visage et corps SPF 30 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Guinot b0a95379-998a-4cda-bae7-63faf3d6f3c8 2026-09-10 Warnings Exact identifier application number: M020 Sun Logic Lait Solaire Corps SPF 20 AVOBENZONE, HOMOSALATE, OCTOCRYLENE Guinot d9d2cee0-9189-42d0-b1ab-78b97141b128 2026-09-10 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 1226 W AESTHETICS 5b0ef395-a7dd-378e-e063-6394a90a5dce 2026-09-09 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 W Aesthetics 5b0f2c8f-d6fa-5e25-e063-6394a90a084d 2026-09-09 Warnings Exact identifier application number: M020 Baloom 2% Panthenol Hydro Airy Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE. OCTOCRYLENE ARSN KOREA 5148b638-f8a4-fa8b-e063-6294a90ac208 2026-09-08 Warnings Exact identifier application number: M020 Double-Duty Face Moisturizer MOSITURIZING SUNSCREEN Jack Black, LLC 672be406-e3a1-47b4-8ef6-ee2b62baae96 2026-09-08 Warnings Exact identifier application number: M020 Intense Therapy Lip Balm Pineapple Mint SUNSCREEN SKIN PROTECTANT LIP BALM Jack Black, LLC 0862534c-5f48-4f67-a3b8-0876a667556f 2026-09-08 Warnings Exact identifier application number: M020 Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E LIP BALM SPF25 Jack Black, LLC 88e8752d-1fbf-4e28-b79d-7c05ecdce842 2026-09-08 Warnings Exact identifier application number: M020 Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea Butter LIP BALM SUNSCREEN Jack Black, LLC e8730127-2d8d-4b80-ab90-d2f136d9e516 2026-09-08 Warnings Exact identifier application number: M020 Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and Ginger LIP BALM SUNSCREEN Jack Black, LLC d961d22a-2125-41e9-94a3-5b53d12b320f 2026-09-08 Warnings Exact identifier application number: M020 Intense Therapy Lip Balm Asian Pear SUNSCREEN SKIN PROTECTANT LIP BALM Jack Black, LLC acace707-6671-4818-86f2-d9813792157a 2026-09-08 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 58443-0578-4 58443057804 125 mL in 1 BOTTLE (58443-0578-4) 125 ml 2017-10-02 0000-00-00 No No Current