Home NDC 13630-0065 Australian Gold
Product NDC 13630-0065
11-digit product format 136300065
Labeler code 13630
Product ID 13630-0065_e1e83ae8-5ceb-3f27-e053-2a95a90a7a7e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octocrylene, and Oxybenzone
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-04-25
Marketing end 2022-06-30
Substance AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength 8 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 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 13630-0065-4 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AVOBENZONE ACTIVE INGREDIENT G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 DIBUTYL MALEATE INACTIVE INGREDIENT 4X371TMK9K AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1
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 225 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Defense Minerals (Medium) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e2297d4-3649-a749-e063-6294a90ac284 2025-02-14 Warnings Exact identifier application number: M020 Sun Defense Minerals (Light) ZINC OXIDE, TITANIUM DIOXIDE Eminence Organic Skin Care 2e22cfde-10a1-3742-e063-6394a90ac097 2025-02-14 Warnings Exact identifier application number: M020 Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE CMS LAB Inc. 2e5c2add-8ed0-a990-e063-6394a90a87ea 2025-02-14 Warnings Exact identifier application number: M020 Les Duets - Shield of Helios, sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f75a5-6a3b-a129-e063-6394a90a52a0 2025-02-14 Warnings Exact identifier application number: M020 Le Mieux Naked Glow Bronzer SPF 50 SUNSCREEN YB CHEMIA LLC 46465db7-c1f0-6980-e063-6294a90a3ed8 2025-02-14 Warnings Exact identifier application number: M020 Sheer Tint Mineral SPF Serum - Light Light ZINC OXIDE Mineral Fusion brands ac6fdc35-82f8-4805-875e-2aa91aedec6f 2025-02-14 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 50 ZINC OXIDE Peer Pharm Ltd. 3989eebc-7262-4cda-84a1-ca30b638b772 2025-02-13 Warnings Exact identifier application number: M020 Fre Protect Me Lightweight Daily Moisturizer SPF 30 ZINC OXIDE Peer Pharm Ltd. 8ee9f97b-9081-4e0c-aa7a-27a31cbee17a 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Medium Deep ZINC OXIDE Peer Pharm Ltd. 45ed56e1-46cb-46de-b11a-e814a7446e57 2025-02-13 Warnings Exact identifier application number: M020 Fre Glow Me Lightweight Tinted Moisturizer Light Medium ZINC OXIDE Peer Pharm Ltd. 6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry Touch SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Kenvue Brands LLC e99311c2-ed8b-6e60-e053-2a95a90a9bc2 2025-02-13 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 525f7bae-44b8-44e4-93ea-32995eca2566 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen Sunlit SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e093b82-2a36-cc0f-e063-6394a90a4d6d 2025-02-13 Warnings Exact identifier application number: M020 DreamBeam Sunscreen SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC f93b0091-6a41-ae6e-e053-6394a90a86d7 2025-02-13 Warnings Exact identifier application number: M020 Revealer Skin-Improving Foundation SUNSCREEN ZINC OXIDE Kosas Cosmetics, LLC 2e0a0cd6-c302-2017-e063-6394a90a60b8 2025-02-13 Warnings Exact identifier application number: M020 Hi papa KIDS MINERAL FACE SUNSCREEN SUNSCREEN GUANG DONG 3 INS TECHNOLOGY Co., Ltd 2deea723-32a0-da33-e063-6294a90accdd 2025-02-12 Warnings Exact identifier application number: M020 Quick Screen Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE The Quick Flick PTY LTD 3788666e-7efa-43da-95f5-6218b7fcb6ea 2025-02-12 Warnings Exact identifier application number: M020 Dolce AND Gabbana Get Your Healthy Glowy Skin ZINC OXIDE Socoplan 91bf1cca-8d18-4c59-864d-4fd0619c6713 2025-02-12 Warnings Exact identifier application number: M020 Cell Fusion C Aquatica UV Defense Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CMS LAB Inc. 2dfd1f99-5896-1e0f-e063-6394a90aa71d 2025-02-12 Warnings Exact identifier application number: M020 Biore Aqua Rich UV OCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATE KAO USA f9024581-dbab-b7cb-e053-6294a90a8b9a 2025-02-12 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 13630-0065-4 13630006504 177 mL in 1 CAN (13630-0065-4) 177 ml 2012-04-25 0000-00-00 No No Current