Home NDC 58443-0035-4 Australian Gold
Product NDC 58443-0035
Requested package NDC 58443-0035-4
11-digit product format 584430035
Labeler code 58443
Product ID 58443-0035_9c591dec-4d4b-c000-e053-2a95a90a6b67
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octisalate, Octocrylene, and Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises, Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2013-10-14
Marketing end 0000-00-00
Substance AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 10 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 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE INGREDIENT 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE INGREDIENT 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE INGREDIENT 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 AVOBENZONE ACTIVE MOIETY G63QQF2NOX AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTISALATE ACTIVE MOIETY 4X49Y0596W AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OCTOCRYLENE ACTIVE MOIETY 5A68WGF6WM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OXYBENZONE ACTIVE MOIETY 95OOS7VE0Y AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 3-BUTYLPHTHALIDE INACTIVE INGREDIENT 822Q956KGM AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALKYL (C12-15) BENZOATE INACTIVE INGREDIENT A9EJ3J61HQ AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER INACTIVE INGREDIENT 7K68DGG29P AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARAMEL INACTIVE INGREDIENT T9D99G2B1R AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 CARBOMER COPOLYMER TYPE A INACTIVE INGREDIENT 71DD5V995L AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 ISOPROPYLPHTHALIMIDE INACTIVE INGREDIENT 1J1MM83329 AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 METHYLISOTHIAZOLINONE INACTIVE INGREDIENT 229D0E1QFA AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OLETH-10 INACTIVE INGREDIENT JD797EF70J AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 OLIVE OIL INACTIVE INGREDIENT 6UYK2W1W1E AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PHENOXYETHANOL INACTIVE INGREDIENT HIE492ZZ3T AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 POLYSILICONE-15 INACTIVE INGREDIENT F8DRP5BB29 AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SORBITAN MONOOLEATE INACTIVE INGREDIENT 06XEA2VD56 AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 SUNFLOWER OIL INACTIVE INGREDIENT 3W1JG795YI AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TEA TREE OIL INACTIVE INGREDIENT VIF565UC2G AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) INACTIVE INGREDIENT 78GX033D7I AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) 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 58443-0035-4 58443003504 237 mL in 1 BOTTLE, WITH APPLICATOR (58443-0035-4) 237 ml 2013-10-14 0000-00-00 No No Current