Australian Gold

Product NDC: 13630-0020
11-digit product format: 136300020
Labeler code: 13630
Product ID: 13630-0020_e1e83a92-0ccd-374b-e053-2995a90abe92
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octisalate, Octocrylene, Oxybenzone
Dosage form: SPRAY
Route: TOPICAL
Labeler: Prime Packaging, Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-10-23
Marketing end: 2022-06-30
Substance: AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength: 8 mg/mL; 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	13630-0020		D	Discontinued by firm		2026-10-21
excluded package	package	13630-0020	13630-0020-4	D	Discontinued by firm		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 · 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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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	13630-0020-4	`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 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
C12-15 ALKYL BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
DIETHYLHEXYL 2,6-NAPHTHALATE	INACTIVE INGREDIENT	I0DQJ7YGXM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)	INACTIVE INGREDIENT	T9296U138P	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) 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 76 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72e2c71a-da1d-497f-a8b7-491cff951c63	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	19d1432a-96b0-4cef-b13e-895dd41b41d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a06c820-ccd8-47ce-8bbf-7e90da92b1de	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	205e195a-fd30-44f7-9294-e701f0f766d6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5495ff75-0c83-4491-8af7-4aed7a779d7f	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	10bc345d-a5b1-4b70-bfa6-a2d7816904bf	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	30268b6e-d42a-4314-b82f-24f9e81cca2a	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	545c962f-2a59-4d94-8fef-ebdba4127f42	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17c9226b-459c-42fe-ac50-7e26db6b49af	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8cb27c4e-b2f4-4e60-a5ff-7cdda79a3af6	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	bf323e10-5479-44b3-b4b9-b8ca6b0f7688	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WO Warm Olive	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2d6a5133-b847-4ecf-8c33-1cb05aca6b91	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 4WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	275be888-2c52-43ed-846a-55525002edcd	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c73576a6-dbab-4205-add5-876a060b5022	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 7,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ae761ac-df06-4913-a8bf-8ca1be32b5b7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	72c45120-6997-4250-b9b4-1cdb762efe1a	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	166e293f-3874-4fe6-8c20-2162b0d11cf1	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b048c7a5-8a71-47ea-945c-44a2d663dfa7	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 6N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	e0463aa0-8e56-4dcd-8cd8-776e8a3915f2	2026-01-16	Warnings	Exact identifier application number: M020
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 wless Skin True Foundation SPF 20 10N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	038939d6-b9a5-4cb6-a818-6f7cf3f106fa	2026-01-16	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
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13630-0020-4	13630002004	177 mL in 1 CAN (13630-0020-4)	177 ml	2013-10-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DIETHYLHEXYL 2,6-NAPHTHALATE - Prime Packaging, Inc. \| Prime Enterprises, Inc.	Prime Packaging, Inc. \| Prime Enterprises, Inc.	2022-06-20	HUMAN OTC DRUG LABEL	4