Australian Gold

Product NDC: 13630-0167
11-digit product format: 136300167
Labeler code: 13630
Product ID: 13630-0167_e64d027f-2258-a8c5-e053-2a95a90ae1b0
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form: SPRAY
Route: TOPICAL
Labeler: Prime Packaging, Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-05-06
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 26 mg/mL; mg/mL; mg/mL; mg/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	13630-0167		D	Discontinued by firm		2026-10-16
excluded package	package	13630-0167	13630-0167-4	D	Discontinued by firm		2026-10-16

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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13630-0167-4	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13630-0167-4	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13630-0167-4	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13630-0167-4	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13630-0167-4	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13630-0167-4	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13630-0167-4	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13630-0167-4	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13630-0167-4	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	13630-0167-4	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	13630-0167-4	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	13630-0167-4	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	13630-0167-4	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
13630-0167-4	2024-05-02	C162847	48780-1	1030e365-2b95-111a-e063-dadaa90a10e2	Australian Gold Botanical SPF 50 Continuous spray
13630-0167-4	2024-01-30	C162847	48780-1	1030e365-2b95-111a-e063-dadaa90a10e2	Australian Gold Botanical SPF 50 Continuous spray

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 83 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunscreen Lotion118mL	ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%	Foshan Sugar Max Cosmetics CO.,Ltd	46355437-4068-9d03-e063-6394a90ae52c	2026-01-09	Warnings	Exact identifier application number: M020
ST MORIZ SUNCARE FACE SUNSCREEN SPF30	SUNCARE FACE SUNSCREEN SPF30	Aopline Biotechnology (Guangzhou) Co., Ltd.	47f26af6-4d02-3506-e063-6294a90a0fe6	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sun 6 SPF Tan and Care Carrot	OCTINOXATE	Farmasi US LLC	67de9257-70f3-4444-a4a2-a8d7425fcc0e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen SPF30 Broad Spectrum	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	d9197dce-20a3-4d10-807c-ec84ab902165	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Lumi Radiance Brightening	OCTOCRYLENE, OCTINOXATE, AVOBENZONE	Farmasi US LLC	adf5621b-7cf0-53b3-e053-2a95a90a8058	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. TUNA SUN PROTECTOR LIP BALM SPF 15	HOMOSALATE, OCTINOXATE	FARMASI US LLC	1dbd5e83-2248-4751-88d9-b446ccc3c61e	2026-01-09	Warnings	Exact identifier application number: M020
Dr. C. Tuna Sunscreen 50 SPF UVA UVB Protection Face and Body Sun	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE	Farmasi US LLC	27fdbd2b-60de-4906-a176-5c5198d9925b	2026-01-09	Warnings	Exact identifier application number: M020
Skin Metal Stealth	ZINC OXIDE	Skin Metal	47f5d7de-5d32-041a-e063-6394a90ab6f9	2026-01-09	Warnings	Exact identifier application number: M020
Salt and Blue Body Sunscreen SPF 30	ZINC OXIDE 20%	Salt + Blue LLC	47f764a0-e9ad-ef66-e063-6394a90a8de5	2026-01-09	Warnings	Exact identifier application number: M020
City Sunscreen serum Broad Spectrum SPF 30 Supergoop	HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE	Supergoop, LLC	61766f7b-512d-45b5-b652-e09975a3d3fc	2026-01-09	Warnings	Exact identifier application number: M020
Defense Refresh (Re)Setting Mist SPF 40	AVOBENZONE, HOMOSALATE , OCTISALATE, OCTOCRYLENE	Supergoop LLC	b95ad8e3-978b-b721-e053-2a95a90a1e54	2026-01-09	Warnings	Exact identifier application number: M020
Daily Dose Vitamin C and Broad Spectrum SPF 40 Serum	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	aed0dd03-1695-a5a9-e053-2995a90acfdc	2026-01-09	Warnings	Exact identifier application number: M020
Hand Screen Broad Spectrum Sunscreen SPF 40	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972ebab9-3f2f-6716-e053-2a95a90a5c75	2026-01-09	Warnings	Exact identifier application number: M020
Glow Oil Broad Spectrum Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	972c68e7-b137-34c6-e053-2a95a90a77d6	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Coconut SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	ee045b64-7a95-4378-8183-e6e556f3b184	2026-01-09	Warnings	Exact identifier application number: M020
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	I World LLC	967d0657-18fc-4e4a-b52d-442df43329f1	2026-01-09	Warnings	Exact identifier application number: M020
PLAY SPF 30 Lip Shield Coconut	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0b8b850-bdfe-5563-e053-2995a90a51a7	2026-01-09	Warnings	Exact identifier application number: M020
Play SPF 30 Lip Shield Strawberry	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	b0a49142-53c3-5b7a-e053-2995a90a581d	2026-01-09	Warnings	Exact identifier application number: M020
Glow Stick Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Supergoop, LLC	61e543e3-9ace-6440-e053-2991aa0a9647	2026-01-09	Warnings	Exact identifier application number: M020
(RE) Setting 100% Mineral Powder Translucent Broad Spectrum Sunscreen SPF 35	ZINC OXIDE	Supergoop, LLC	af5c9801-26ce-5c60-e053-2995a90ab457	2026-01-09	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
13630-0167-4	13630016704	152 g in 1 CAN (13630-0167-4)	152 g	2019-05-06	0000-00-00	No	No	Current