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 238 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ECLIPSE SPF 50 ALL SHADES TITANIUM DIOXIDE, ZINC OXIDE SCIENCE OF SKINCARE LLC 49df51e6-be9a-41be-b3e1-bfc062aaceaa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Mineral Suns Stick - Tinted SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 44a6ff9b-8067-4f32-acb2-4ede54c79e6e 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNKISSED ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC c45b59d8-0196-4dce-bfaa-57c47f655fe8 2025-01-09 Warnings Exact identifier application number: M020 TiZO Tinted Lip Protection SPF 45 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 1088fbf6-5790-490d-b272-ec281b4b76fa 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Prime and Protect SPF 40 (Non-Tinted) TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD f106f52b-2157-46c7-9f7c-50f43a649050 2025-01-09 Warnings Exact identifier application number: M020 NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKS ZINC OXIDE SUNSCREEN Bentley Laboratories, LLC 5c98bacb-8bbd-47b8-8987-50be1ed34fc0 2025-01-09 Warnings Exact identifier application number: M020 CoTZ Face Moisture ZINC OXIDE Fallien Cosmeceuticals, LTD db682516-6c8f-4009-a9ec-e21dfc64ce15 2025-01-09 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light Medium OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty bcd22c9a-2db6-4653-9ab5-825f3f5cc420 2025-01-08 Warnings Exact identifier application number: M020 L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light OCTOCRYLENE, ZINC OXIDE L'BRI Health & Beauty c66c2a54-97c8-4904-a44a-b3cf790837f5 2025-01-08 Warnings Exact identifier application number: M020 Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE Tempo Industries, Inc. af9aa56d-2f8a-55b9-e053-2a95a90a3258 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen Probiotics SPF55 ZINC OXIDE Hello Bello 0191b2e4-bcc5-541a-e063-6294a90a0e78 2025-01-08 Warnings Exact identifier application number: M020 Kids Face and Body Sunscreen SPF 50 ZINC OXIDE Hello Bello 01cc4ea0-e3de-32f1-e063-6394a90a1375 2025-01-08 Warnings Exact identifier application number: M020 Baby Mineral Sunscreen SPF55 ZINC OXIDE Hello Bello 0190eeaf-c5a0-3253-e063-6294a90a43c4 2025-01-08 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF 50 ZINC OXIDE Hello Bello 01cc205b-a345-262a-e063-6394a90a955c 2025-01-08 Warnings Exact identifier application number: M020 Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen Unscented ZINC OXIDE Eco Lips, Inc. febabad6-0bf2-a3f8-e053-6294a90a3aeb 2025-01-08 Warnings Exact identifier application number: M020 LESS EVERY TONE SPF 30 ZINC OXIDE Happy Farm Botanicals, Inc. e91ded4b-987d-17a8-e053-2995a90adc2e 2025-01-08 Warnings Exact identifier application number: M020 Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE ETHEREAL AESTHETICS LLC 065d17cf-bea5-137f-e063-6394a90aeeb3 2025-01-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE SERRAO, E JOHN MD FACOG fea61544-6684-ad34-e053-6294a90a48f3 2025-01-08 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE New Beginnings Tattoo Removal fea87de3-116f-4774-e053-6394a90a0aad 2025-01-08 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