Home NDC 13630-0024 Australian Gold
Product NDC 13630-0024
11-digit product format 136300024
Labeler code 13630
Product ID 13630-0024_e1f63334-0b88-f937-e053-2a95a90a0fa8
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging, Inc.
Application M020
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-11-06
Marketing end 2022-09-30
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 25 mg/mL; mg/mL; 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 13630-0024-4 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 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 DIETHYLHEXYL 2,6-NAPHTHALATE INACTIVE INGREDIENT I0DQJ7YGXM AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) INACTIVE INGREDIENT T9296U138P AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, 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 137 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ProtectME Tinted Mineral SPF 40 TITANIUM DIOXIDE, ZINC OXIDE PUREFECTION LA, INC. 33dccd5d-8db1-f699-e063-6394a90a59a2 2025-12-10 Exact identifier application number: M020 Protect ME Non Tinted Mineral SPF 40 ZINC OXIDE PUREFECTION LA, INC. 34a2d716-b853-752e-e063-6394a90a52e2 2025-12-10 Exact identifier application number: M020 Tinted Mineral Moisturizing Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ABOUT FACE AESTHETICS, INC. 364728b4-e0ff-8466-e063-6394a90a0089 2025-12-10 Exact identifier application number: M020 tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d42661-e511-1dfc-e063-6294a90a9ed7 2025-12-10 Exact identifier application number: M020 non-tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Skin & Bare It LLC 35d3ef95-621c-f193-e063-6294a90ac3ee 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen tinted ZINC OXIDE Skin & Bare It LLC 35d45df5-e9bf-1a08-e063-6294a90ae04f 2025-12-10 Exact identifier application number: M020 face Plus body sunscreen non-tinted ZINC OXIDE Skin & Bare It LLC 361ef750-0f0e-bd01-e063-6294a90a0020 2025-12-10 Exact identifier application number: M020 bare skin smooth mineral tint ZINC OXIDE Skin & Bare It LLC 361f2933-73d5-a9d7-e063-6394a90abb3c 2025-12-10 Exact identifier application number: M020 Smoothing Mineral Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE DANIEL BEHROOZAN MD A MEDICAL CORPORATION 32721b87-aef1-d759-e063-6394a90a40d3 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Stick TITANIUM DIOXIDE, ZINC OXIDE Shelley Bennett Skincare 326e9a14-5fb6-6a6e-e063-6294a90adece 2025-12-10 Exact identifier application number: M020 3-in-1 Daily Vanishing Tinted Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 325dae60-01cc-a120-e063-6294a90a2ef2 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE Shelley Bennett Skincare 326e49b8-e21c-0df0-e063-6394a90a2ebc 2025-12-10 Exact identifier application number: M020 Daily Moisturizing Glow Sunscreen Cream ZINC OXIDE SHELLEY BENNET SKINCARE 325df1f8-1678-c07c-e063-6294a90a96fb 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bafa0b-d253-c263-e063-6394a90ad1e4 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35ba578f-a842-7eec-e063-6394a90a1165 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb3b36-3886-ea8e-e063-6394a90a5257 2025-12-10 Exact identifier application number: M020 Non Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bc3994-1f72-2bbf-e063-6294a90ac2f1 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bccadf-6fc8-abd0-e063-6294a90aaa2e 2025-12-10 Exact identifier application number: M020 Mineral Sunscreen Zinc Oxide ZINC OXIDE Hirschman, Kristina 35bb9341-355f-4910-e063-6294a90a8c15 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Hirschman, Kristina 35bd61ff-0d66-a9b3-e063-6394a90ad940 2025-12-10 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 13630-0024-4 13630002404 177 mL in 1 CAN (13630-0024-4) 177 ml 2013-11-06 0000-00-00 No No Current