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		2026-10-15
excluded package	package	13630-0022	13630-0022-4	D	Discontinued by firm		2026-10-15

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 17 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ivory Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f25ba-61d5-6a94-e063-6394a90a46e9	2026-06-26	Warnings	Exact identifier application number: M020
Simply Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f4799-9122-8db5-e063-6394a90a5132	2026-06-26	Warnings	Exact identifier application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f6d2c-9b8c-aa52-e063-6294a90a787e	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Pineapple Sunrise	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c30a422-b22a-ca79-e063-6294a90a19a9	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Pineapple Sunrise	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c37a994-79dd-9720-e063-6294a90a7f34	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Waikiki Beach Coconut	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c37b8d7-de72-f534-e063-6294a90aeab7	2026-06-26	Warnings	Exact identifier application number: M020
UV Daily Hydration Tinted	OCTISALAT AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	02e71602-13e1-43b3-9cba-a75e46cccacc	2026-06-25	Warnings	Exact identifier application number: M020
Coral Isle SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rocky Mountain	5515f562-62d9-c6ee-e063-6294a90a9ea6	2026-06-25	Warnings	Exact identifier application number: M020
SPF30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Zhejiang Ayan Biotech Co.,Ltd.	6759b9f7-296a-4c06-9198-b4e824e0bdc9	2026-06-25	Warnings	Exact identifier application number: M020
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	551928b4-74bb-3f6c-e063-6294a90a6b83	2026-06-25	Warnings	Exact identifier application number: M020
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	5519290c-b040-6a37-e063-6394a90a8a1d	2026-06-25	Warnings	Exact identifier application number: M020
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	551ab7d1-dd2f-c6d8-e063-6394a90aff65	2026-06-25	Warnings	Exact identifier application number: M020
Alabaster Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	551b8c21-3afc-c804-e063-6294a90a5156	2026-06-25	Warnings	Exact identifier application number: M020
Scalp and Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Only Balds LLC	551bf10e-598c-1400-e063-6294a90a4af1	2026-06-25	Warnings	Exact identifier application number: M020
Bare Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f20b2-9a2e-70f3-e063-6394a90a9337	2026-06-25	Warnings	Exact identifier application number: M020
MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	BRAND GENOME CO., Ltd.	51c07375-e81d-8572-e063-6394a90ab5b0	2026-06-24	Warnings	Exact identifier application number: M020
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	54fc80b7-8f6c-e2be-e063-6394a90a4b59	2026-06-24	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	365613b6-36ec-0512-e063-6294a90a9532	2026-06-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	235a9430-b445-8d5c-e063-6394a90a9354	2026-06-24	Warnings	Exact identifier application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	54ecaea7-dafe-9694-e063-6394a90ae3b5	2026-06-23	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