Australian Gold

Product NDC
13630-0065
Requested package NDC
13630-0065-4
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage13630-006513630-0065-4DDiscontinued by firm2026-10-27

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
DIBUTYL MALEATEINACTIVE INGREDIENT4X371TMK9KAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
DIETHYLHEXYL 2,6-NAPHTHALATEINACTIVE INGREDIENTI0DQJ7YGXMAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138PAUSTRALIAN GOLD BROAD SPECTRUM SPF 8 (AVOBENZONE, OCTOCRYLENE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RAUSTRALIAN 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 57 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENEOld East Main Co.db876d34-1af9-4e0a-9e9a-32a8b00e94052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENEOld East Main Co.2ea288fe-815d-4568-9592-55ea428448fa2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.cea1c223-c9d4-42ac-8c5b-c0ca647d57a12026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOld East Main Co.00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ef48288b-533f-4924-ba12-fc8cb83643d42026-03-02WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.e6976bf4-ad77-4953-858f-4a0ec7f4300c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ba9331ef-3744-4072-80a2-af95c6f7ee052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.1a53d8d5-e650-4825-8a3b-7cf42c36e3e52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.086dfda5-9fe7-46b4-9964-4977b86cfdd52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ce9a2139-c5c2-43e2-bd51-1f14ace594d92026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Bask SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESurfside Skincare, Inc. dba Bask Suncare49a30877-e39f-46a3-e063-6394a90a8dd22026-03-02WarningsExact identifier
application number: M020
Sunscreen SPF30AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf6014a97-12d3-4f42-86de-866a206c6c062026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS VANILLAEpic Laboratories, LLC02488aad-28be-4ffb-e063-6294a90ad01e2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS ORIGINALEpic Laboratories, LLC1872eefd-d702-ac9f-e063-6294a90a24ef2026-03-02WarningsExact identifier
application number: M020
JAYSUING White Birch Moisturizing Sunscreen CreamTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.4c174691-cc32-b2e4-e063-6294a90a0f732026-03-02WarningsExact identifier
application number: M020
Kypris Pot of Shade Heliotropic Broad Spectrum SPF 30 Sunscreen And PrimerZINC OXIDEKypris Beauty LLCa5d5f7bd-d7bf-4a5c-8530-b9d5d74754c32026-02-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0065-413630006504177 mL in 1 CAN (13630-0065-4) 177 ml2012-04-252022-06-30NoNoCurrent