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 148 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb19ed7-8cee-ce80-e063-6394a90ad3dc 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb14c4f-a435-aa6e-e063-6394a90a7d8d 2025-12-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 40 Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc4f701-eea2-7913-e063-6294a90a8693 2025-12-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 40 Tinted TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc55e8c-41d6-15cc-e063-6394a90ac543 2025-12-08 Warnings Exact identifier application number: M020 Zinc Oxide SPF 40 Tinted ZINC OXIDE Skin Restoration Aesthetics 2fc60a39-789b-3d11-e063-6294a90a9abf 2025-12-08 Warnings Exact identifier application number: M020 Zinc Oxide SPF 40 Non-Tinted ZINC OXIDE Skin Restoration Aesthetics 2fc68041-acfe-8db6-e063-6294a90ad8ba 2025-12-08 Warnings Exact identifier application number: M020 Daily Tinted Mineral SPF TITANIUM DIOXIDE, ZINC OXIDE Skin Restoration Aesthetics 2fc6e168-b2c1-bf9d-e063-6394a90aade7 2025-12-08 Warnings Exact identifier application number: M020 Ultra Solar Shield non-tinted moisturizing mineral SPF 40 ZINC OXIDE Joyce Kelly Enterprises 365bdf7a-c034-beef-e063-6394a90a4dd7 2025-12-08 Exact identifier application number: M020 UV Shade tinted matte mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Joyce Kelly Enterprises 365b3a1e-8410-da06-e063-6294a90a462f 2025-12-08 Exact identifier application number: M020 Solar Shield non-tinted matte mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Joyce Kelly Enterprises 365b68a0-0f89-0f43-e063-6294a90a5eee 2025-12-08 Exact identifier application number: M020 Ultra UV Shade tinted moisturizing mineral SPF 40 ZINC OXIDE Joyce Kelly Enterprises 365ba78a-b7df-a31f-e063-6394a90a1673 2025-12-08 Exact identifier application number: M020 Mineral Sunscreen tinted TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 3000a0a7-2b51-b832-e063-6294a90a4a08 2025-12-08 Warnings Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 3001028b-bb36-04ec-e063-6294a90a1e49 2025-12-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 3001aa3a-cc8b-6ad4-e063-6394a90a223f 2025-12-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Face 5, LLC 300268ff-f9ef-1006-e063-6294a90a5fdf 2025-12-08 Warnings Exact identifier application number: M020 Illuminating Daily SPF 40 Lightly Tinted ZINC OXIDE Face 5, LLC 3001ef4f-4cbb-8931-e063-6394a90a5cef 2025-12-08 Warnings Exact identifier application number: M020 Illuminating Daily SPF40 Non-Tinted ZINC OXIDE Face 5, LLC 300218c9-65cf-d984-e063-6294a90a1517 2025-12-08 Warnings Exact identifier application number: M020 Illuminating Daily SPF 40 Lightly Tinted ZINC OXIDE Face 5, LLC 300303e7-ef89-7449-e063-6294a90ac811 2025-12-08 Warnings Exact identifier application number: M020 Clear Path Tinted Facial Sunscreen TITANIUM DIOXIDE, ZINC OXIDE LULUS SPA BOUTIQUE 37657755-fa82-88a0-e063-6394a90ade47 2025-12-08 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Dermacare 376468ce-8d9b-b672-e063-6294a90a0bd1 2025-12-08 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