Home NDC 58443-0197 Australian Gold
Product NDC 58443-0197
11-digit product format 584430197
Labeler code 58443
Product ID 58443-0197_9c58b46a-0c90-a377-e053-2a95a90ad113
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, octocrylene and oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-10-07
Marketing end 0000-00-00
Substance OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 20 mg/mL; mg/mL; 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 · 30 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 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 58443-0197-3 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 58443-0197-3 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 58443-0197-3 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58443-0197-3 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 58443-0197-3 Australian GoldBROAD SPECTRUM SPF 30 X-treme Sport Sunscreen 50 mL in 1 BOTTLE LOTION 50 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 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 (C10-C30)ALKYL METHACRYLATE ESTER INACTIVE INGREDIENT XH2FQZ38D8 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ALLANTOIN INACTIVE INGREDIENT 344S277G0Z AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ALPHA-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 C12-15 ALKYL BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 COCOA BUTTER INACTIVE INGREDIENT 512OYT1CRR AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 KAKADU PLUM INACTIVE INGREDIENT 0ZQ1D2FDLI AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 N-BUTYLPHTHALIMIDE INACTIVE INGREDIENT 5TH1DKT35E AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 POLYSILICONE-15 INACTIVE INGREDIENT F8DRP5BB29 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58443-0197 AUSTRALIAN GOLD BROAD SPECTRUM SPF 30 X-TREME SPORT SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.] 3 Legacy NDC, 1 package rows 20200118_2187db35-3636-5a06-e054-00144ff88e88.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58443-0197-3 58443019703 50 mL in 1 BOTTLE (58443-0197-3) 50 ml 2015-10-07 0000-00-00 No No Current