Australian Gold

Product NDC: 13630-0022
11-digit product format: 136300022
Labeler code: 13630
Product ID: 13630-0022_e1e84d40-7a99-7e13-e053-2995a90aa07e
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octisalate, Octocrylene
Dosage form: SPRAY
Route: TOPICAL
Labeler: Prime Packaging, Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-10-31
Marketing end: 2023-02-28
Substance: AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 16 mg/mL; mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	13630-0022		D	Discontinued by firm		2026-11-13
excluded package	package	13630-0022	13630-0022-4	D	Discontinued by firm		2026-11-13

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 · 24 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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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	13630-0022-4	`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
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
DIETHYLHEXYL 2,6-NAPHTHALATE	INACTIVE INGREDIENT	I0DQJ7YGXM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)	INACTIVE INGREDIENT	T9296U138P	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AUSTRALIAN GOLD BROAD SPECTRUM SPF 15 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]	1

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 198 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AHAVA Extreme Daily Firmness And Protection Broad Spectrum SPF30	HOMOSALATE, OCTISALATE, AVOBENZONE, ENSULIZOLE, AND OCTOCRYLENE	AHAVA Dead Sea Laboratories Ltd	b22af9ef-4b69-4e70-a65d-f421e1d178af	2025-08-01	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Broad Spectrum SPF 30 and Neutrogena Collagen Bank Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	3b4dbc5a-0754-0e71-e063-6394a90aa63c	2025-08-01	Warnings	Exact identifier application number: M020
Kids Tallow Sunscreen SPF50	NON-NANO ZINC OXIDE 25%	FOUNDATION COMMERCE INC	3b4eca91-965f-66c6-e063-6394a90a78ca	2025-08-01	Warnings	Exact identifier application number: M020
Vigority Tallow Sunscreen SPF30	NON-NANO ZINC OXIDE 19%	FOUNDATION COMMERCE INC	3b4f5941-15ae-a760-e063-6394a90a2abe	2025-08-01	Warnings	Exact identifier application number: M020
Pipette Mineral Sunscreen SPF 50	ZINC OXIDE	Pipette LLC	3a10657a-bc16-181d-e063-6294a90a485b	2025-08-01	Warnings	Exact identifier application number: M020
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BCM Cosmetique SAS	3f0500cc-013b-7069-e063-6294a90a1a5f	2025-08-01	Warnings	Exact identifier application number: M020
Daily Antioxidant Mineral Sunscreen	ZINC OXIDE	MONIKA G KIRIPOLSKY MD INC.	3b3d7ff2-1463-8d8e-e063-6394a90a5ac8	2025-07-31	Warnings	Exact identifier application number: M020
Shaklee Shield Sheer Mineral Body Sunscreen SPF 30	ZINC OXIDE	Shaklee Corp	c9b8e04c-11ee-4c4f-8693-aa4dc6e66aca	2025-07-31	Warnings	Exact identifier application number: M020
Equate SUNSCREEN spf 50 SPORT broadspectrum	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Walmart	4e5280b2-1437-4d97-bb4c-db1a1632fea7	2025-07-31	Warnings	Exact identifier application number: M020
Tallow Sunscreen SPF 30	NON-NANO ZINC OXIDE 19%	FOUNDATION COMMERCE INC	3b410ed7-c629-e39c-e063-6294a90a12f6	2025-07-31	Warnings	Exact identifier application number: M020
Face Reality Brilliant Defense Sunscreen SPF 50	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	Face Reality,LLC	618f58b7-2f29-4dff-8c3a-4fdbe1eb8ce4	2025-07-29	Warnings	Exact identifier application number: M020
Face Reality Power Mineral Sunscreen SPF 50	ZINC OXIDE	Face Reality,LLC	8c502e11-6e97-46d6-8775-1bbafaeb18f8	2025-07-29	Warnings	Exact identifier application number: M020
SPF30 unseen sunscreen stick 01	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	3afa3bdb-e924-55c1-e063-6394a90af352	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	003123d2-9675-fdd2-e063-6294a90a0130	2025-07-28	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Face SPF 70	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	20e0badf-fe25-1d27-e063-6294a90a7cfe	2025-07-28	Warnings	Exact identifier application number: M020
Basin Santas Cookies SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b016dcf-fb74-916f-e063-6294a90a683d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Retail Concepts of Minnesota, Inc.	3b01c6a4-2230-c83e-e063-6294a90aa66d	2025-07-28	Warnings	Exact identifier application number: M020
Basin Peppermint Swirl SPF 15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b022c84-00a5-ece9-e063-6294a90a09bd	2025-07-28	Warnings	Exact identifier application number: M020
Basin Winter Berry Blast SPF15 Broad Spectrum Sunscreen Lip Balm	AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	Retail Concepts of Minnesota, Inc.	3b02c3f2-a43a-0d29-e063-6394a90a76b5	2025-07-28	Warnings	Exact identifier application number: M020
KARA VITA Moisturizing Sunscreen with DNArescue	OXYBENZONE, AVOBENZONE, OCTINOXATE, OCTISALATE, AND HOMOSALATE	Kara Vita, Inc.	2130e9ac-5946-4b00-94d0-a78fd1ccfd13	2025-07-25	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
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
13630-0022-4	13630002204	177 mL in 1 CAN (13630-0022-4)	177 ml	2013-10-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALCOHOL - Prime Packaging, Inc. \| Prime Enterprises, Inc.	Prime Packaging, Inc. \| Prime Enterprises, Inc.	2022-06-20	HUMAN OTC DRUG LABEL	4