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 263 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SUNLEYA Age minimizing sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE C.F.E.B. Sisley 67498d45-0871-4806-8854-81d3e50c4b90 2024-12-10 Warnings Exact identifier application number: M020 SUPER CREME SOLAIRE CORPS Body sun care SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE C.F.E.B. Sisley 1c774aa7-8963-4221-b4b0-b894bd1b941f 2024-12-10 Warnings Exact identifier application number: M020 Tinted Sunscreen Cream SPF 30 4-Deep Amber TITANIUM DIOXIDE, ZINC OXIDE C.F.E.B. - Sisley 5599922a-b020-477c-a44c-1db42ec5756a 2024-12-10 Warnings Exact identifier application number: M020 SUNLEYA Age minimizing sun care SPF 50 plus AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENE C.F.E.B. Sisley 7c9fadaf-b961-4df0-89ae-87141b50b2c1 2024-12-10 Warnings Exact identifier application number: M020 Tinted Sunscreen SPF 30 1-Natural TITANIUM DIOXIDE, ZINC OXIDE C.F.E.B. - Sisley b3d53a10-2647-492a-a05f-b97c3f716aa8 2024-12-10 Warnings Exact identifier application number: M020 Tinted Sunscreen SPF 30 2-Golden TITANIUM DIOXIDE, ZINC OXIDE C.F.E.B. - Sisley 389cbce6-552c-4633-babd-7b672632f0b9 2024-12-10 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 28f08236-1f01-d759-e063-6294a90adcfa 2024-12-10 Warnings Exact identifier application number: M020 Blistex Five Star Lip Protection Broad Spectrum HOMOSALATE, OCTISALATE, AVOBENZONE, AND DIMETHICONE Blistex Inc. 47b57317-7df5-442e-a3a4-1d44fe278ac6 2024-12-10 Warnings Exact identifier application number: M020 AHAVA Brightening Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE AHAVA - Dead Sea Laboratories Ltd 724bbb91-e273-4926-9ad6-a1657ffe4cd8 2024-12-10 Warnings Exact identifier application number: M020 ATTITUDE Sunly Mineral Sunscreen Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d83c576-5dfb-583a-e063-6294a90a2a28 2024-12-09 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Face Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d833e3b-5330-3c5b-e063-6394a90a2ed2 2024-12-09 Warnings Exact identifier application number: M020 ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d9533ba-5606-4116-e063-6294a90ad3b1 2024-12-09 Warnings Exact identifier application number: M020 ATTITUDE Sunly Kids Mineral Sunscreen Stick Unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d82121d-1dc2-cd99-e063-6394a90aa766 2024-12-09 Warnings Exact identifier application number: M020 Attitude Kids Oatmeal sensitive mineral sunscreen unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 310e66a2-8714-4016-87f4-81c1fef19ec9 2024-12-09 Warnings Exact identifier application number: M020 Attitude Oatmeal sensitive mineral sunscreen unscented SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude b6b8733d-6431-4ed2-9350-c63bb901c804 2024-12-09 Warnings Exact identifier application number: M020 BIO SPECTRA ATTITUDE ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 06245c8c-93e8-4ebb-bab0-3db64dc178b9 2024-12-09 Warnings Exact identifier application number: M020 BANANA BOAT KIDS SPF 65 CLEAR SUNSCREEN AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC dc7b0d17-d7c8-433f-e053-2995a90a477d 2024-12-09 Warnings Exact identifier application number: M020 Sheer Zinc SPF 30 ZINC OXIDE Allure Labs b6b45dac-41d0-1b55-e053-2a95a90acf61 2024-12-09 Warnings Exact identifier application number: M020 Broad Spectrum SPF30 Mineral Sunscreen ZINC OXIDE Allure Labs dafc8e62-7c99-1f6d-e053-2995a90a7791 2024-12-09 Warnings Exact identifier application number: M020 Prevention Daily Tinted Moisturizer SPF 30 ZINC OXIDE AND TITANIUM DIOXIDE Allure Labs ed883d63-777c-e924-e053-2995a90a162a 2024-12-09 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 13630-0240-4 13630024004 200 mL in 1 CAN (13630-0240-4) 200 ml 2022-03-07 0000-00-00 No No Current