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 208 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR SA f9266687-73d2-dac9-e053-6394a90ac2a1 2025-06-20 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE BEL STAR SA fd0465aa-df1e-ce1c-e053-6294a90a2302 2025-06-20 Warnings Exact identifier application number: M020 FEIBTH TALLOW SUNSCREEN TALLOW SUNSCREEN Guangzhou Qiexiran Cosmetics Co., Ltd. 37ead2b1-12d4-af92-e063-6394a90af0d6 2025-06-19 Warnings Exact identifier application number: M020 LipBOMB TITANIUM DIOXIDE, ZINC OXIDE FLEUR DE VIE LLC 37ef4c1e-2183-a277-e063-6394a90ae2df 2025-06-19 Exact identifier application number: M020 Bioresist reinforcing effect face moisturizer SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR S A 99d7525d-b636-7f8e-e053-2a95a90a2080 2025-06-19 Warnings Exact identifier application number: M020 Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Translucide OCTINOXATE, ZINC OXIDE BEL STAR S A c4d56723-3953-fb8e-e053-2a95a90a69d3 2025-06-19 Warnings Exact identifier application number: M020 SPF 50 Daily UV Defense Broad Spectrum Sunscreen OCTINOXATE, ZINC OXIDE Vi Medical Products, INC 2d814f8a-23b5-209f-e063-6394a90a5091 2025-06-19 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETICS BY RIKI LLC 37f2c5ed-c2f5-e569-e063-6294a90a15b1 2025-06-19 Exact identifier application number: M020 Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel OCTINOXATE, ZINC OXIDE BEL STAR S A c4f95c1b-acbe-4bb7-e053-2995a90a9120 2025-06-19 Warnings Exact identifier application number: M020 LBEL NUDE SKIN ULTRA LIGHT MATTE FOUNDATION WITH VITAMINS SPF 20 ALMENDRA 230-N OCTINOXATE, ZINC OXIDE Bel Star S.A. d22fde8a-ba14-2cc7-e053-2a95a90a0e53 2025-06-19 Warnings Exact identifier application number: M020 Correct and Protect Serum Broad Spectrum SPF 45 ZINC OXIDE Murad, LLC dba6e01b-a8ec-4812-bbe0-e418bb067032 2025-06-19 Warnings Exact identifier application number: M020 Truffoire Truffle Brightening OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. e3068ecf-0bee-4e8a-a439-4bb707a2845d 2025-06-18 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 383de98b-65b5-4398-a876-87367dc01d0b 2025-06-18 Warnings Exact identifier application number: M020 CB Multi-Active Moisturizer with SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. d9557a6c-78e9-4b01-8a4b-e0eceb511c4e 2025-06-18 Warnings Exact identifier application number: M020 1000 Roses CC Color plus Correct Sheer Beige SPF 30 ZINC OXIDE Andalou naturals 2e7f3570-f710-41dd-95a0-7c0613b317a2 2025-06-17 Warnings Exact identifier application number: M020 Skin by Scottie Beach Mode Mineral Sunscreen Roll-On SPF 30 TITANIUM DIOXIDE, ZINC OXIDE SKIN CARE BY SCOTTIE LLC a9afa58c-f438-48c6-bd30-eda41334df74 2025-06-16 Warnings Exact identifier application number: M020 Wellage Real Hyaluronic Watery Glow Sun Screen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Hugel, Inc. 37aa2f7b-afa4-5cc9-e063-6294a90ae741 2025-06-16 Warnings Exact identifier application number: M020 Dermaka Sunscreen SPF 42, Tinted TITANIUM DIOXIDE, ZINC OXIDE DERMAKA SKIN PRODUCTS 9a967cd1-9eec-4255-b14b-ac2e33e4dbf0 2025-06-16 Warnings Exact identifier application number: M020 Elizabeth Arden Eight Hour Hydraplay SPF 40 OCTISALATE, HOMOSALATE, AVOBENZONE, OCTOCRYLENE Revlon Consumer Products Corp 2cc74177-0f62-106e-e063-6394a90a6e28 2025-06-16 Warnings Exact identifier application number: M020 BALI BODY SPF15 BRONZE SHIMMERING TANNING AVOBENZONE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 240d4d80-641c-ac57-e063-6394a90abe75 2025-06-16 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