Austalian Gold

Product NDC: 58443-0589
11-digit product format: 584430589
Labeler code: 58443
Product ID: 58443-0589_ed9e76ff-2bd8-172c-e053-2995a90a198a
Type: HUMAN OTC DRUG
Nonproprietary name: Octisalate, Avobenzone, Octocrylene, Homosalate
Dosage form: SPRAY
Route: TOPICAL
Labeler: Prime Enterprises Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-10-30
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 30 g/mL; g/mL; g/mL; g/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58443-0589		I	Inactivated by FDA		2026-10-23
excluded package	package	58443-0589	58443-0589-4	I	Inactivated by FDA		2026-10-23

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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`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	58443-0589-4	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0589-4	2024-01-30	C162847	48780-1	1030e365-3e1d-111a-e063-dadaa90a10e2	Australian Gold Instant Bronzer Spray Gel Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58443-0589-4	Austalian GoldBroad Spectrum SPF 30 Sunscreen	237 mL in 1 BOTTLE, SPRAY	SPRAY	237		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58443-0589	AUSTALIAN GOLD BROAD SPECTRUM SPF 30 SUNSCREEN (OCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE) SPRAY [PRIME ENTERPRISES INC.]	1	Legacy NDC, 1 package rows	20221119_ed9e76ff-2bd7-172c-e053-2995a90a198a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 79 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
THE ENERGIST Multi-Defense Broad Spectrum Sunscreen SPF 50	ZINC OXIDE	Noble Panacea Labs, Inc.	aed57f81-4b7d-42dc-993e-6bb10f93b02a	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	0d9f132c-7630-4261-a0f8-fc7a4377731f	2026-01-16	Warnings	Exact identifier application number: M020
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUM	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	f292da7d-ffd2-41c3-9a64-619aab19ff18	2026-01-15	Warnings	Exact identifier application number: M020
Multivit Sun Protector	TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONE	Noon Aesthetics M.R. Ltd	abdb560d-29be-41dc-ad23-54ea571acb14	2026-01-15	Warnings	Exact identifier application number: M020
BeautyBarrier	ZINC OXIDE	NAKED SUNDAYS PTY LTD	45740afa-230d-4dd5-e063-6394a90a102f	2026-01-15	Warnings	Exact identifier application number: M020
Glow This Way	OCTISALATE, OCTOCRYLENE, ZINC OXIDE, AVOBENZONE, HOMOSALATE	Koco Life LLC	4619cf96-987a-3e88-e063-6294a90afbe9	2026-01-15	Warnings	Exact identifier application number: M020
Reef safe lip balm 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	486930f2-026b-14b4-e063-6394a90aa031	2026-01-15	Warnings	Exact identifier application number: M020
DRAMATICALLY DIFFERENT MOISTURIZING LTN BROAD SPECTRUM SPF35	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	CLINIQUE LABORATORIES LLC	316bf6f8-7d30-2560-e063-6294a90afb8a	2026-01-15	Warnings	Exact identifier application number: M020
Wellcare Sunstick Lip Balm	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE	BAMKO, LLC	ef977575-7ef0-fc09-e053-2a95a90a8993	2026-01-15	Warnings	Exact identifier application number: M020
Bali Body Sheer Glow Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bali Body Pty Ltd	4872793c-a7c0-1b65-e063-6394a90a8b3a	2026-01-15	Warnings	Exact identifier application number: M020
Getaway Glow SPF 30 Radiant Sunscreen Broad Spectrum SPF 30 Sunscreen	ZINC OXIDE	Volition Beauty	2631de4b-66e3-0547-e063-6394a90a822c	2026-01-15	Warnings	Exact identifier application number: M020
AGE RESET Restore Plus Protect Day Cream Broad Spectrum SPF 30	ZINC OXIDE	SKINN COSMETICS, LLC	350ed168-ab3b-f314-e063-6394a90a8bbf	2026-01-15	Warnings	Exact identifier application number: M020
StriVectin TL Advanced Tightening Neck and Chest Broad Spectrum SPF 35 Sunscreen	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	StriVectin Operating Company, Inc.	4873a262-a19b-555e-e063-6394a90a182a	2026-01-15	Warnings	Exact identifier application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	e843bb6b-257f-4425-95bc-41774e032a09	2026-01-15	Warnings	Exact identifier application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50	SUNSCREEN	The Center Brands, LLC	1e18f1dd-a4e4-455a-9699-5634b9559678	2026-01-15	Warnings	Exact identifier application number: M020
First Aid Beauty Ultra Repair Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	485c345f-0928-fa1a-e063-6294a90aa856	2026-01-14	Warnings	Exact identifier application number: M020
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30	ZINC OXIDE	LABORATOIRES DRUIDE INC	19af4441-31b2-72db-e063-6394a90a813c	2026-01-14	Warnings	Exact identifier application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30	ZINC OXIDE	Sqween LLC	9c3cf35b-4bde-46e3-8abd-5f4d1ad6e486	2026-01-14	Warnings	Exact identifier application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30	TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES DRUIDE INC	0799ac38-9a41-6579-e063-6394a90ac4b6	2026-01-14	Warnings	Exact identifier application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30	ZINC OXIDE	LABORATOIRES DRUIDE INC	0b412e24-baf6-e68e-e063-6394a90a5f49	2026-01-14	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58443-0589-4	58443058904	237 mL in 1 BOTTLE, SPRAY (58443-0589-4)	237 ml	2019-10-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Australian Gold Instant Bronzer Spray Gel Broad Spectrum SPF 30	Prime Enterprises Inc.	2022-11-16	HUMAN OTC DRUG LABEL	1