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		2026-10-27
excluded package	package	13630-0022	13630-0022-4	D	Discontinued by firm		2026-10-27

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 176 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9d9419-a7e1-bc42-e063-6394a90af511	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e8af968-77d5-1dcd-e063-6394a90a6699	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9e95c3-4ac8-5962-e063-6294a90a0c02	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9dd230-b087-cda7-e063-6394a90ae084	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9b0642-53ed-ec94-e063-6394a90aec3d	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d977158-8b5d-66ac-e063-6294a90a4d5c	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0eae4b71-60be-9715-e063-6294a90af463	2025-10-20	Warnings	Exact identifier application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen	ZINC OXIDE	Attitude DBA 9055-7588 Qubec Inc.	9ed70230-980c-474c-9f72-a6be0f355124	2025-10-20	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE OCTISALATE OCTOCRYLENE	Edgewell Personal Care Brands LLC	419b8043-7921-ca77-e063-6394a90a99ba	2025-10-20	Warnings	Exact identifier application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	419c8718-6b9e-3df7-e063-6294a90a1e3b	2025-10-20	Warnings	Exact identifier application number: M020
Sonni SunDay Serum	ZINC OXIDE	Sonni	419d4ada-fe9b-b774-e063-6394a90a3d09	2025-10-20	Warnings	Exact identifier application number: M020
Lip Clear Lysine Plus Coldstick	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	66f84e56-4a5d-4b71-8bd3-79961e7bf4fe	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Strawberry Lip Treatment	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	2cafc97f-4cd3-4755-b394-3802c28d4ed5	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Tangerine Lip Treatment	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	8a00194e-9e28-4257-82e5-59bc44f7897d	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Coldstick	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	c9318a8c-ba3b-4068-84df-110c9005ee1d	2025-10-20	Warnings	Exact identifier application number: M020
Terez Honor Hydro Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEWYCREAM INC	418d054b-436f-6aa3-e063-6294a90a0f56	2025-10-19	Warnings	Exact identifier application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Cosmocos Co., Ltd	41129799-85ed-2de2-e063-6394a90ab40c	2025-10-17	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	c5a67314-e5b2-4dd6-94e9-39c2f286c346	2025-10-17	Warnings	Exact identifier application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN	ZINC OXIDE	Lion Pose Inc.	0310407b-fb74-aa8b-e063-6294a90ad841	2025-10-17	Warnings	Exact identifier application number: M020
Thrive Daily Defense Sunscreen Balm SPF30	ZINC OXIDE	Thrive Natural Care, Inc	1266bd05-1971-a7f0-e063-6394a90a089c	2025-10-17	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