Home NDC 13630-0022 Australian Gold
Product NDC 13630-0022
11-digit product format 136300022
Labeler code 13630
Product ID 13630-0022_e1e84d40-7a99-7e13-e053-2995a90aa07e
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Octocrylene
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-10-31
Marketing end 2023-02-28
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength 16 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 13630-0022-4 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 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) 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 112 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365f3c48-15a6-2d32-e063-6394a90aad78 2025-12-16 Exact identifier application number: M020 Non Tinted Mineral Sunscreen ZINC OXIDE Natur LLC 365fffa2-b846-7dd3-e063-6394a90a47cb 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Natur LLC 36603550-9c3d-5e33-e063-6394a90adfc9 2025-12-16 Exact identifier application number: M020 Shield And Protect Tinted ZINC OXIDE TRILOGY LABORATORIES, LLC 37f00e51-1123-c04c-e063-6294a90abed8 2025-12-16 Exact identifier application number: M020 Shield And Protect ZINC OXIDE TRILOGY LABORATORIES, LLC 37f09dd5-084f-3c80-e063-6394a90a7a53 2025-12-16 Exact identifier application number: M020 Non Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766496f-231c-f98c-e063-6294a90aae08 2025-12-16 Exact identifier application number: M020 Tinted Facial Mineral Protectant TITANIUM DIOXIDE, ZINC OXIDE EUROPEAN SKIN AND MASSAGE STUDIO 3766b0d8-20e6-a227-e063-6294a90af4da 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37515807-e29a-3916-e063-6394a90a1ffd 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 374f866d-eb52-61e3-e063-6394a90a77c7 2025-12-16 Exact identifier application number: M020 Tinted Lip Protection TITANIUM DIOXIDE, ZINC OXIDE WECARE FRISCO PLLC 3750c23d-c3f8-fac3-e063-6394a90a135e 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 ZINC OXIDE WECARE FRISCO PLLC 374fe86e-cbe8-f911-e063-6294a90a9600 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 37507b14-fc01-5e27-e063-6294a90afd50 2025-12-16 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 375203a6-2ab8-2a80-e063-6294a90ada72 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen ZINC OXIDE WECARE FRISCO PLLC 3751caa3-867e-5901-e063-6294a90ab6bd 2025-12-16 Exact identifier application number: M020 Auset Tinted Replenishing Daily Protection ZINC OXIDE SHAYLA BOGER SKIN THERAPY LLC 37da48d6-8f12-ec97-e063-6294a90a699c 2025-12-16 Exact identifier application number: M020 Morning Replenish ZINC OXIDE KATHY JONES AESTHETHICS LLC 37da711e-840b-2f2a-e063-6294a90ab16c 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE KATHY JONES AESTHETHICS LLC 37dab729-5988-5eba-e063-6294a90ac6b7 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tory Sullivan, M.D., P.A. 36241e60-f02a-50a7-e063-6394a90a6390 2025-12-16 Exact identifier application number: M020 Ageless All Fitz ZINC OXIDE A.Wall Beauty LLC 37670cb1-ac75-5049-e063-6394a90a4d0a 2025-12-16 Exact identifier application number: M020 Tinted Replenishing Daily Protection ZINC OXIDE Tory Sullivan, M.D., P.A. 36244b27-20e5-f370-e063-6294a90a1f6c 2025-12-16 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 13630-0022-4 13630002204 177 mL in 1 CAN (13630-0022-4) 177 ml 2013-10-31 0000-00-00 No No Current