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 227 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2ee9b3dc-91cd-1af9-e063-6394a90a78e1 2025-02-24 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 2edc79f8-aac5-15eb-e063-6394a90a9736 2025-02-23 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc25651b-0e30-c325-e053-2995a90a809e 2025-02-21 Warnings Exact identifier application number: M020 CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-C OCTINOXATE, ZINC OXIDE BEL STAR S A dc129cd6-a173-d2b3-e053-2a95a90aa04e 2025-02-21 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Tinted AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eec6e7c8-17fe-f34b-e053-2995a90a78a0 2025-02-20 Warnings Exact identifier application number: M020 Drops AVOBENZONE OCTISALATE OCTOCRYLENE Vacation Inc. 1319d6ea-a580-79c5-e063-6394a90a4dca 2025-02-20 Warnings Exact identifier application number: M020 Vacation SPF 50 Super Spritz Face Mist AVOBENZONE, OCTISALATE, OCTOCRYLENE Vacation Inc. f67fbe98-93ce-2882-e053-2a95a90ab713 2025-02-20 Warnings Exact identifier application number: M020 REPAIRWEAR UPLIFTING FIRMING BROAD SPECTUM SPF 15 - NORMAL COMBO TO COMBINATION oily OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 10edc0c1-9359-4c7a-a56e-bad06fea0056 2025-02-20 Warnings Exact identifier application number: M020 Mineral SPF 30 Brush-On Sun Defense ZINC OXIDE Mineral Fusion 29733dba-8824-461e-be44-335d6fe50d60 2025-02-19 Warnings Exact identifier application number: M020 Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC 20cd4d96-2046-3a50-e063-6394a90a1219 2025-02-18 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 30 Pina Colada AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC edc59de7-c817-1a59-e053-2995a90a3408 2025-02-17 Warnings Exact identifier application number: M020 Liplux SPF 30 Lip Balm CLASSIC COOLA LLC b47b5f3a-43f3-ae7a-e053-2995a90ae16d 2025-02-17 Warnings Exact identifier application number: M020 COOLA Classic Body SPF 50 Fragrance Free AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA, LLC ed207afe-0b10-74c7-e053-2a95a90a9b87 2025-02-17 Warnings Exact identifier application number: M020 Avon Skin-So-Soft Bug Guard plus SPF 30 Sunscreen Gentle Breeze Insect Repellent Sunscreen OCTINOXATE, OXYBENZONE, OCTISALATE The Avon Company 2e5d6c93-f091-5388-e063-6394a90ad560 2025-02-17 Warnings Exact identifier application number: M020 KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE e.l.f. Cosmetics, Inc 31a98dc7-4b99-d845-e063-6394a90a2670 2025-02-17 Warnings Exact identifier application number: M020 Ultra sheer mineral sunscreen PRO SPF30 ZINC OXIDE Eden Brands Inc. 2ce06566-2eb0-9a00-e063-6394a90a9ba9 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2dff0386-e151-089a-e063-6394a90a0f53 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Airy Stick Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CMS LAB Inc. 2dffc699-3b56-2c70-e063-6294a90ae249 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Sheer) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2082aa-5ae3-2c04-e063-6294a90a140b 2025-02-14 Warnings Exact identifier application number: M020 Coola SPF 30 Mineral Sunscreen Fragrance Free ZINC OXIDE COOLA, LLC edc6048e-0ea0-41c5-e053-2a95a90a96d9 2025-02-14 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