Australian Gold

Product NDC: 13630-0240
11-digit product format: 136300240
Labeler code: 13630
Product ID: 13630-0240_e5f85082-4d6b-75a8-e053-2995a90a1d6a
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: 2022-03-07
Marketing end: 0000-00-00
Substance: AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength: 25 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	13630-0240		I	Inactivated by FDA		2026-10-21
excluded package	package	13630-0240	13630-0240-4	I	Inactivated by FDA		2026-10-21

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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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	13630-0240-4	`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
13630-0240-4	2024-01-30	C162847	48780-1	1030e365-52c9-111a-e063-dadaa90a10e2	Australian Gold SPF 50 Sport Continuous Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
13630-0240-4	Australian GoldBroad Spectrum SPF 50	200 mL in 1 CAN	SPRAY	200		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13630-0240	AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1	Legacy NDC, 1 package rows	20220812_e5f84f4a-00e5-b457-e053-2995a90a3c9d.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 158 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cetaphil Sun Tinted Face SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	22413f93-7219-4726-b741-2392e576b34a	2025-11-24	Warnings	Exact identifier application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15	ZINC OXIDE AND TITANIUM DIOXIDE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	28e23498-953f-47c0-838c-bbf0e858d903	2025-11-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	203c9d86-45d7-efcc-e063-6394a90acefb	2025-11-23	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	615c5349-7fff-4145-9d65-1687247163be	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Face SPF 60	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	3cee59ad-f5e1-487d-b9cc-597664c62dac	2025-11-21	Warnings	Exact identifier application number: M020
Aveeno Protect Plus Hydrate Sunscreen Broad Spectrum Body SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	0e905f47-a1d8-4c5a-8247-d7328d2cb4af	2025-11-21	Warnings	Exact identifier application number: M020
SPF 50 Sport Sunscreen GoodSense	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Geiss, Destin, & Dunn, Inc	a22baebd-1f4d-6eae-e053-2a95a90afe51	2025-11-21	Warnings	Exact identifier application number: M020
Everyday Sun Defense	ZINC OXIDE	Hommerejuvenate, Inc.	05aa1a1a-9e4f-2781-e063-6394a90aef6b	2025-11-21	Warnings	Exact identifier application number: M020
innisfree Daily UV Defense Sunscreen	AVOBENZONE, HOMOSALATE, AND OCTISALATE LOTION	Innisfree Corporation	0e9b6697-28a3-f69f-e063-6394a90a9d11	2025-11-20	Warnings	Exact identifier application number: M020
SULWHASOO PERFECTING CUSHION NO. 25	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	Amorepacific Corporation	8d420e4b-c778-3ed4-e053-2995a90a59a9	2025-11-20	Warnings	Exact identifier application number: M020
Protect Prevent Daily Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Norwex Usa, Inc.	f527a8c5-b05e-5f3c-e053-2995a90aa1a3	2025-11-20	Warnings	Exact identifier application number: M020
Norwex Lip Glaze Broad Spectrum SPF 30 Hazelnut	ZINC OXIDE	Norwex Usa, Inc.	440bd831-ee0b-b527-e063-6294a90a9333	2025-11-20	Warnings	Exact identifier application number: M020
PRO-COLLAGEN SKIN PROTECTION FLUID SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Elemis Ltd.	23f9222f-60ba-72fb-e063-6394a90a9965	2025-11-20	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Mozzie Repellant	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca866e-adc3-5a4f-e063-6394a90a1d1d	2025-11-20	Warnings	Exact identifier application number: M020
Sandra Plasencia Green Tea Daily SPF 50 Moisturizer	TITANIUM DIOXIDE	Sandra Plasencia Skincare	43ef1f93-0e89-0a35-e063-6394a90afb51	2025-11-19	Warnings	Exact identifier application number: M020
Sunkissed by Heaven Unscented Sunscreen SPF 50	ZINC OXIDE	Sunkissed By Heaven, LLC	09dbd05a-dd07-43c3-b3d0-68f8f4b3e86d	2025-11-19	Warnings	Exact identifier application number: M020
KOVR Military grade sunscreen for women	ZINC OXIDE	ACTIVE LIFE INC	4d0691ad-ca1b-4ca7-b94a-7bbaaf6f6dae	2025-11-19	Warnings	Exact identifier application number: M020
Dynamic Resurfacing SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	fc64720c-060c-4f33-8c76-96456fac270d	2025-11-19	Warnings	Exact identifier application number: M020
Daily Defence Shield SPF 30	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	ELEMIS Limited	b2b6de93-47c8-4b6e-9fb9-8bdc8909271a	2025-11-19	Warnings	Exact identifier application number: M020
Duke Cannon Supply Co. Daily Defense Face Mineral Sunscreen Broad Spectrum SPF 32	ZINC OXIDE	DUKE CANNON SUPPLY CO.	0c47278b-2ec2-81ab-e063-6294a90ac937	2025-11-19	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
13630-0240-4	13630024004	200 mL in 1 CAN (13630-0240-4)	200 ml	2022-03-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Australian Gold SPF 50 Sport Continuous Spray	Prime Packaging, Inc. \| Prime Enterprises, Inc.	2022-08-11	HUMAN OTC DRUG LABEL	1