Home NDC 58443-0566-9 Australian Gold
Product NDC 58443-0566
Requested package NDC 58443-0566-9
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 · 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 58443-0566-9 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 1 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HERA SILKYSTAY FOUNDATION 37W1 TITANIUM DIOXIDE Amorepacific Corporation 5f4105f3-d08b-edb5-e063-6394a90ad28b 2026-11-01 Warnings Exact identifier application number: M020 Note Mattifying Extreme Wear Foundation 130 Cool Rose OCTINOXATE ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI c52d92d9-e228-4840-aacc-ed97a6173443 2026-10-29 Warnings Exact identifier application number: M020 HERA SILKYSTAY FOUNDATION 28O1 TITANIUM DIOXIDE Amorepacific Corporation 5ec77f7a-4621-ac0c-e063-6294a90a3f70 2026-10-26 Warnings Exact identifier application number: M020 RoC Barrier Renew AM Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 020aa79f-4fd6-1ea1-e063-6394a90a4464 2026-10-14 Warnings Exact identifier application number: M020 Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 AVOBENZONE, OCTOCRYLENE Merle Norman Cosmetics, Inc d5c97cdc-7f98-1a4f-e053-2995a90a089b 2026-10-12 Warnings Exact identifier application number: M020 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light) TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health Inc. 4f8756bf-5b0d-5269-e063-6294a90ae6dc 2026-10-02 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 52bbc6cd-4bc2-7859-e063-6394a90ac87d 2026-10-01 Warnings Exact identifier application number: M020 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
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