Australian Gold

Product NDC: 13630-0065
11-digit product format: 136300065
Labeler code: 13630
Product ID: 13630-0065_e1e83ae8-5ceb-3f27-e053-2a95a90a7a7e
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone, Octocrylene, and Oxybenzone
Dosage form: SPRAY
Route: TOPICAL
Labeler: Prime Packaging, Inc.
Application: M020
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-04-25
Marketing end: 2022-06-30
Substance: AVOBENZONE; OCTOCRYLENE; OXYBENZONE
Active strength: 8 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	13630-0065		D	Discontinued by firm		2026-11-13
excluded package	package	13630-0065	13630-0065-4	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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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	13630-0065-4	`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, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE INGREDIENT	5A68WGF6WM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OCTOCRYLENE	ACTIVE MOIETY	5A68WGF6WM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
DIBUTYL MALEATE	INACTIVE INGREDIENT	4X371TMK9K	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
DIETHYLHEXYL 2,6-NAPHTHALATE	INACTIVE INGREDIENT	I0DQJ7YGXM	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)	INACTIVE INGREDIENT	T9296U138P	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	AUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND 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 217 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Health Sport 100 Clear	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CVS PHARMACY	0a245b1b-eaf6-7011-e063-6294a90ab68f	2025-03-26	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Apple Pie flavored	LIP BALM SPF15 APPLE PIE FLAVORED	LS Promotions Inc	3145bd6d-0ece-e9d5-e063-6294a90afb9d	2025-03-26	Warnings	Exact identifier application number: M020
HEB Glow 40 Tinted Sunscreen Face Primer	AVOBENZONE, OCTISALATE, OCTOCRYLENE	H.E.B.	3146bcd9-d562-9ba6-e063-6294a90a37aa	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	3146fb5f-1fb5-f09f-e063-6294a90a6206	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Glow Body Oil Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B.	31473cc9-08f5-39e3-e063-6294a90aa499	2025-03-26	Warnings	Exact identifier application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide Sunscreen	ZINC OXIDE	H.E.B.	314776a8-a562-3dd2-e063-6394a90ab1b9	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	31478f5a-88f4-4b01-e063-6394a90a04b7	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Trader Joe's Company	3147c08f-c3f2-aef1-e063-6294a90a5c44	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mangonada Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	3147ef18-9029-6d5b-e063-6394a90acee0	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	31487bad-a756-9050-e063-6394a90acacc	2025-03-26	Warnings	Exact identifier application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40	ZINC OXIDE	Trader Joe's Company	3148c00f-21bb-c05f-e063-6394a90af0e8	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314b8147-fe7a-0698-e063-6394a90a872c	2025-03-26	Warnings	Exact identifier application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	H.E.B	314bcf42-ca01-0fa5-e063-6294a90a5fc8	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Murad, LLC	1e5d494b-dccf-4ba1-89de-0bb4ba5b8d38	2025-03-26	Warnings	Exact identifier application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Murad, LLC	ac6163fb-dbc1-432f-a590-86d31c93b29b	2025-03-26	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral Medium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	e17dc640-30e9-441b-a212-ef1508af7944	2025-03-25	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Vanilla	LIP BALM SPF15 VANILLA	LS Promotions Inc	312d0dc5-3933-ecfe-e063-6294a90a9b66	2025-03-25	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Blueberry Cobbler	LIP BALM SPF15 BLUEBERRY COBBLER	LS Promotions Inc	312fb7b0-86a9-ca88-e063-6294a90a76c8	2025-03-25	Warnings	Exact identifier application number: M020
Lip Balm SPF15 Peppermint	LIP BALM SPF15 PEPPERMINT	LS Promotions Inc	3130be1c-0167-2389-e063-6394a90aa61d	2025-03-25	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 30	SUNSCREEN SPF 30	OL PHARMA TECH LLC. (Drs. Pharmacy)	052dea5d-a775-8dc2-e063-6294a90a4f19	2025-03-25	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
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
13630-0065-4	13630006504	177 mL in 1 CAN (13630-0065-4)	177 ml	2012-04-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ALKYL (C12-15) BENZOATE - Prime Packaging, Inc. \| Prime Enterprises, Inc.	Prime Packaging, Inc. \| Prime Enterprises, Inc.	2022-06-20	HUMAN OTC DRUG LABEL	4