Home NDC 58443-0021-4 Australian Gold
Product NDC 58443-0021
Requested package NDC 58443-0021-4
11-digit product format 584430021
Labeler code 58443
Product ID 58443-0021_9c58a9ba-3229-3acc-e053-2a95a90ac743
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octocrylene, and Oxybenzone
Dosage form OIL
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-11-13
Marketing end 0000-00-00
Substance AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength 4 mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 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 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 ACETYLATED LANOLIN ALCOHOLS INACTIVE INGREDIENT SNN716810P AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 BLACK OLIVE INACTIVE INGREDIENT 2M6QWV94OC AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 BUTYLATED HYDROXYTOLUENE INACTIVE INGREDIENT 1P9D0Z171K AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 CARROT SEED OIL INACTIVE INGREDIENT 595AO13F11 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 CETYL ACETATE INACTIVE INGREDIENT 4Q43814HXS AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 COCONUT OIL INACTIVE INGREDIENT Q9L0O73W7L AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 DIETHYLHEXYL SYRINGYLIDENEMALONATE INACTIVE INGREDIENT 3V5U97P248 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) INACTIVE INGREDIENT AG75W62QYU AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 ISOPROPYL LINOLEATE INACTIVE INGREDIENT 4MW1E9AT4H AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 SOY ACID INACTIVE INGREDIENT HBA528N3PW AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1 TRICAPRIN INACTIVE INGREDIENT O1PB8EU98M AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) OIL [PRIME ENTERPRISES, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0021-4 58443002104 237 mL in 1 BOTTLE (58443-0021-4) 237 ml 2012-11-13 0000-00-00 No No Current