Home NDC 58443-0076-4 Australian Gold
Product NDC 58443-0076
Requested package NDC 58443-0076-4
11-digit product format 584430076
Labeler code 58443
Product ID 58443-0076_9c590808-1971-58f1-e053-2995a90a2c6d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octocrylene and Oxybenzone
Dosage form GEL
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-11-21
Marketing end 0000-00-00
Substance AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength 10 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58443-0076-4 Australian GoldBROAD SPECTRUM SPF 4 237 mL in 1 BOTTLE GEL 237 3
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) GEL [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 3-BUTYLPHTHALIDE INACTIVE INGREDIENT 822Q956KGM AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 7K68DGG29P AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT 809Y72KV36 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 KAKADU PLUM INACTIVE INGREDIENT 0ZQ1D2FDLI AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 OLETH-10 INACTIVE INGREDIENT JD797EF70J AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 POLYSILICONE-15 INACTIVE INGREDIENT F8DRP5BB29 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) INACTIVE INGREDIENT 5041RX63GN AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0076 AUSTRALIAN GOLD BROAD SPECTRUM SPF 4 (AVOBENZONE, OCTOCRYLENE AND OXYBENZONE) GEL [PRIME ENTERPRISES, INC.] 3 Legacy NDC, 1 package rows 20200118_c5ad40de-49ad-4e59-b601-fccffd2fc298.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0076-4 58443007604 237 mL in 1 BOTTLE (58443-0076-4) 237 ml 2013-11-21 0000-00-00 No No Current