Home NDC 58443-0566 Australian Gold
Product NDC 58443-0566
11-digit product format 584430566
Labeler code 58443
Product ID 58443-0566_e805e7be-5a96-0d5a-e053-2a95a90aa694
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-04-20
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 29 mg/mL; mg/mL; mg/mL; mg/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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 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 58443-0566-9 Australian GoldBroad Spectrum SPF 50 3700 mL in 1 TUBE LOTION 3700 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0566 AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 Legacy NDC, 1 package rows 20220908_e805e88b-32a2-fb28-e053-2995a90ace99.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 20 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Amrit Ocean Resort Mineral Sunscreen SPF 50 ZINC OXIDE Solvyn Skin, LLC 112364cd-a445-46c2-b2f3-f9705d682cf6 2026-06-15 Warnings Exact identifier application number: M020 Kiss My Face Purely Mineral Face Factor 50 Sunscreen SPF 50 ZINC OXIDE Windmill Health Products, LLC 9771aa6d-a797-42d5-919b-3bf67ef5e040 2026-06-15 Warnings Exact identifier application number: M020 Cellular Swiss UV Protection Veil SPF30 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE La Prairie, Inc. dd946a3b-74b9-4ebd-b82f-0350f8f72834 2026-06-15 Warnings Exact identifier application number: M020 365 WHOLE FOODS MARKET SPORT MINERAL SPF 30 ZINC OXIDE Whole Foods Market, Inc. 6caf656c-246f-469e-84f8-98f80b84c65e 2026-06-15 Warnings Exact identifier application number: M020 EVIL GOODS TALLOW SUNSCREEN SPF50 ZINC OXIDE Moes Group LLC 543058d4-f375-d702-e063-6394a90a2640 2026-06-14 Warnings Exact identifier application number: M020 LASSO TALLOW SUNSCREEN SPF 50 ZINC OXIDE Moes Group LLC 54312883-1d40-121e-e063-6294a90a247d 2026-06-14 Warnings Exact identifier application number: M020 SFL SUNSCREEN - SOL DEFENSE SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Lifeline Medical, Inc 5438c185-31c9-c51e-e063-6394a90ae9ef 2026-06-14 Warnings Exact identifier application number: M020 Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE SKINBETTER SCIENCE LLC 54106748-9810-d3ff-e063-6394a90a5b7a 2026-06-12 Warnings Exact identifier application number: M020 Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE SKINBETTER SCIENCE LLC 5410e0ed-aed5-3279-e063-6294a90a0c3e 2026-06-12 Warnings Exact identifier application number: M020 Target Up and Up Ultra Light Dry-Touch SPF 70 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 5411f284-f4ed-4e0e-e063-6294a90af1f6 2026-06-12 Warnings Exact identifier application number: M020 Target Up and Up Oil Control SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TARGET CORPORATION 54141120-7682-9c05-e063-6394a90a877e 2026-06-12 Warnings Exact identifier application number: M020 Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER Atlantic Medical Products , LLC 1a2ab632-6443-1aa9-e063-6394a90a0c05 2026-06-11 Warnings Exact identifier application number: M020 it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE IT COSMETICS, LLC f2990320-b61d-40b8-ba79-18d6b37e7f52 2026-06-11 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc 6c1c9ae3-650f-4cf6-bf21-d3d5229ec2fa 2026-06-11 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE SICOS ET CIE 3c196ac0-dc07-40ad-865c-8177c75c935a 2026-06-11 Warnings Exact identifier application number: M020 BelleJoss BROAD SPECTRUM SPF 50 BROAD SPECTRUM SPF 50 Guangzhou Liyan Cosmetics Technology Co., Ltd. 53e1b5ba-45fc-e811-e063-6394a90a65ac 2026-06-10 Warnings Exact identifier application number: M020 MilaMiAmor SPF50 Sunscreen Lotion50mL OCTINOXATE 7.5%, ZINC OXIDE 5% Foshan Sugar Max Cosmetics CO.,Ltd 5379c00f-8222-6d12-e063-6294a90a8fad 2026-06-10 Warnings Exact identifier application number: M020 HEY HOTTIE Shimmer dry oil mist sunscreen spf30 OCTOCRYLENE,OCTINOXATE Guangdong Aimu Biological Technology Co., Ltd 53f19c01-0011-bc70-e063-6294a90ab879 2026-06-10 Warnings Exact identifier application number: M020 SUNPLUS Solar Sheer SPF 50 OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE SUNPLUS SKIN CARE LLC 86bffd22-dded-404e-8d8e-4c54082ce50f 2026-06-09 Warnings Exact identifier application number: M020 Acewink Sunscreen SUNSCREEN SPRAY Shenzhen Qiming Biotechnology Co., Ltd. 53d19fa8-6f0e-2c11-e063-6294a90abb03 2026-06-09 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 58443-0566-9 58443056609 3700 mL in 1 TUBE (58443-0566-9) 3700 ml 2022-04-20 0000-00-00 No No Current