Home NDC 13630-0240 Australian Gold
Product NDC 13630-0240
11-digit product format 136300240
Labeler code 13630
Product ID 13630-0240_e5f85082-4d6b-75a8-e053-2995a90a1d6a
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-03-07
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 25 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 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 13630-0240-4 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13630-0240-4 Australian GoldBroad Spectrum SPF 50 200 mL in 1 CAN SPRAY 200 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13630-0240 AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 Legacy NDC, 1 package rows 20220812_e5f84f4a-00e5-b457-e053-2995a90a3c9d.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 189 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dolce and Gabbana Blueberry Nutri Tint SPF 20 2C Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 761ce50c-2bf5-4ed0-91ac-9c47f8790ddb 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 3W Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 2781b921-eb0d-4270-addf-47301577b28c 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 5N Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 893434a1-72b8-4f0f-bfaa-2c9d775d7e27 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 7N Light ZINC OXIDE Dolce & Gabbana Beauty S.R.L 199d97a2-d32b-45ab-a43d-30522b0ca596 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 10N Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 638eafb5-08a8-425f-893f-d6609b868e2b 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 9C Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 41fd80a9-2c6f-4f3e-a37d-e781965ddc55 2025-09-05 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 11W Light Medium ZINC OXIDE Dolce & Gabbana Beauty S.R.L 50bac9fb-5b81-4cdd-9eae-ec9530fc46c3 2025-09-05 Warnings Exact identifier application number: M020 Jack Black L.L.C. AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM Jack Black L.L.C. 3e0eb291-6bda-2f26-e063-6294a90ac466 2025-09-05 Warnings Exact identifier application number: M020 Jack Black AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM Jack Black L.L.C. 3d5fafb9-62c9-ec69-e063-6394a90af8b9 2025-09-05 Warnings Exact identifier application number: M020 Jack Black AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM Jack Black L.L.C. 3e0f655e-6100-f1dd-e063-6394a90af7b7 2025-09-05 Warnings Exact identifier application number: M020 Daily Body Moisturizer Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Baxter Laboratories Pty. Ltd. 3e115ef1-f039-4c72-e063-6394a90a7e64 2025-09-05 Warnings Exact identifier application number: M020 Truskin SPF 30 Mineral Sunscreen Facial Serum ZINC OXIDE Allure Labs 3e13299f-8d5d-373b-e063-6394a90ab256 2025-09-05 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b52f29-c1a0-c673-e063-6294a90a9a7a 2025-09-05 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b8003f-40be-3380-e063-6294a90a4f6b 2025-09-05 Warnings Exact identifier application number: M020 MAYDAY Everyday Sunscreen SPF 30 ZINC OXIDE Omniche Consumer Products Co. 3f53fb40-6347-46b0-979c-3522d9948198 2025-09-04 Warnings Exact identifier application number: M020 PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1 ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDE Hangzhou Jingshen Trading Co., Ltd. 18130858-429c-4ed4-a75b-5bc014481250 2025-09-04 Warnings Exact identifier application number: M020 Introstem PrismaStem Face Shield Cream OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. dd91374a-e3fc-42f1-a660-86b32a0cc8b8 2025-09-04 Warnings Exact identifier application number: M020 MEDICUBE COLLAGEN GLOW SUNSCREEN HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE APR US INC 34fae072-536c-ad41-e063-6394a90af0af 2025-09-03 Warnings Exact identifier application number: M020 Basin Sugar Plum SPF 15 Broad Spectrum Sunscreen Lip Balm AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE Retail Concepts of Minnesota, Inc. 3de75cec-955e-4b3a-e063-6394a90a1543 2025-09-03 Warnings Exact identifier application number: M020 Basin Mint SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Retail Concepts of Minnesota, Inc. 3de7d21b-4f88-d80c-e063-6394a90a8e4c 2025-09-03 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 13630-0240-4 13630024004 200 mL in 1 CAN (13630-0240-4) 200 ml 2022-03-07 0000-00-00 No No Current