Home NDC 58443-0032-3 Australian Gold
Product NDC 58443-0032
Requested package NDC 58443-0032-3
11-digit product format 584430032
Labeler code 58443
Product ID 58443-0032_9c58cced-783c-baef-e053-2995a90a383c
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone,Homosalate, Octisalate, and Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-01-25
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 29 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 · 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 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE INGREDIENT V06SV4M95S AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 HOMOSALATE ACTIVE MOIETY V06SV4M95S AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CALENDULA OFFICINALIS FLOWER INACTIVE INGREDIENT P0M7O4Y7YD AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE A INACTIVE INGREDIENT 71DD5V995L AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CHAMOMILE INACTIVE INGREDIENT FGL3685T2X AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 DIHYDROXYACETONE INACTIVE INGREDIENT O10DDW6JOO AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 ENGLISH WALNUT INACTIVE INGREDIENT 1V3SHR7QB7 AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERYL DILAURATE INACTIVE INGREDIENT MFL3ZIE8SK AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 HIGH DENSITY POLYETHYLENE INACTIVE INGREDIENT UG00KM4WR7 AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 L-ERYTHRULOSE INACTIVE INGREDIENT WKK1W5B83O AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYOXYL 20 CETOSTEARYL ETHER INACTIVE INGREDIENT YRC528SWUY AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 SILICA DIMETHYL SILYLATE INACTIVE INGREDIENT EU2PSP0G0W AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 STEARYL ALCOHOL INACTIVE INGREDIENT 2KR89I4H1Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) INACTIVE INGREDIENT 78GX033D7I AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 45 (AVOBENZONE,HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [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 58443-0032-3 58443003203 88 mL in 1 TUBE (58443-0032-3) 88 ml 2013-01-25 0000-00-00 No No Current