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 226 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sum 37 Micro Active Daily Moisture Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG HOUSEHOLD & HEALTH CARE LTD. 2eea94e1-2409-8ad6-e063-6294a90a5df8 2025-03-03 Warnings Exact identifier application number: M020 Sun Defense Minerals (Fair) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e21c9f9-acf8-997b-e063-6394a90ada3f 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e232e8d-4274-68bc-e063-6394a90a942b 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e23d463-fbc1-5718-e063-6294a90a7272 2025-03-01 Warnings Exact identifier application number: M020 Sun Defense Minerals (Deep) ZINC OXIDE Eminence Organic Skin Care 2e24391f-4982-efae-e063-6394a90accaa 2025-03-01 Warnings Exact identifier application number: M020 FRUDIA Blueberry Hydrating Air Fit Sunscreen OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE WELCOS CO.,LTD. 8b2a1baa-e528-48d6-9cd8-c3cb55e0641b 2025-02-28 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL ZINC OXIDE SPF Ventures, LLC 2f1b5454-8bf5-b447-e063-6394a90a743a 2025-02-27 Warnings Exact identifier application number: M020 Clear Defense SPF 45 ZINC OXIDE, OCTINOXATE Private Label Skin Care d681d92f-3501-4fca-b629-096341f20ab1 2025-02-27 Warnings Exact identifier application number: M020 HA Physical Tint SPF 44 ZINC OXIDE, TITANIUM DIOXIDE Private Label Skin Care a5e19d77-703e-41e0-9a02-19227dc6c819 2025-02-27 Warnings Exact identifier application number: M020 Physical Daily Defense Broad Spectrum Sunscreen SPF 40 ZINC OXIDE Private Label Skin Care 18444581-66a4-4eda-a8df-627fa3b4b98a 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILL ZINC OXIDE/TITANIUM DIOXIDE SPF Ventures, LLC 2f069114-9ca8-aed4-e063-6394a90a46d8 2025-02-26 Warnings Exact identifier application number: M020 Sei Bella Tinted BB Moisturizing Cream 230 N Melaleuca Inc. 2f133abb-cad2-2ac8-e063-6294a90aa480 2025-02-26 Warnings Exact identifier application number: M020 BRUSH ON BLOCK SPF 50 KIDS MINERAL ZINC OXIDE SPF Ventures, LLC 2f17b5fe-44da-964b-e063-6394a90ae699 2025-02-26 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2efb73a6-601d-61a4-e063-6294a90af825 2025-02-25 Warnings Exact identifier application number: M020 Rida Hair Research Institute AVOBENZONE,OCTISALATE,OCTOCRYLENE Rida LLC ece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 70 Peach Blossom AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed217698-f552-677e-e053-2995a90acb0a 2025-02-25 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Tropical Coconut AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed0f8249-aba8-b67c-e053-2a95a90af7eb 2025-02-25 Warnings Exact identifier application number: M020 Hydro Essence Broad Spectrum Sunscreen SPF 40 ZINC OXIDE, OCTINOXATE Private Label Skin Care f176c1b1-f539-417f-98b5-69d99365f2f2 2025-02-25 Warnings Exact identifier application number: M020 Sun Defense Minerals (Tan) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2ee82379-6609-fd8e-e063-6294a90acf6c 2025-02-24 Warnings Exact identifier application number: M020 Vacation SPF 50 Classic AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Vacation Inc. f2780cb5-063c-10d3-e053-2995a90a8576 2025-02-24 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