Australian Gold

Product NDC
13630-0240
11-digit product format
136300240
Labeler code
13630
Product ID
13630-0240_e5f85082-4d6b-75a8-e053-2995a90a1d6a
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Prime Packaging, Inc.
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-03-07
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
25 g/mL; g/mL; g/mL; g/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13630-0240IInactivated by FDA2026-10-23
excluded packagepackage13630-024013630-0240-4IInactivated by FDA2026-10-23

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13630-0240-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13630-0240-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13630-0240-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13630-0240-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13630-0240-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13630-0240-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13630-0240-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13630-0240-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13630-0240-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13630-0240-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13630-0240-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13630-0240-4557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13630-0240-48af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13630-0240-4834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13630-0240-41332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13630-0240-42024-01-30C16284748780-11030e365-52c9-111a-e063-dadaa90a10e2Australian Gold SPF 50 Sport Continuous Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13630-0240-4Australian GoldBroad Spectrum SPF 50200 mL in 1 CANSPRAY2001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13630-0240AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]1Legacy NDC, 1 package rows20220812_e5f84f4a-00e5-b457-e053-2995a90a3c9d.zip

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 209 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Environ Skin Care RAD Shield Mineral Sunscreen SPF 30SUNSCREENENVIRON SKIN CARE (PTY) LTD3778547e-11a8-3b30-e063-6394a90ab5b12025-06-13WarningsExact identifier
application number: M020
Voupre Age DefenseOCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.8dfaa076-c62a-47ee-bc5d-75360416fa1a2025-06-13WarningsExact identifier
application number: M020
Instantly DryTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC37624bf6-4949-1b10-e063-6294a90ac4882025-06-12Exact identifier
application number: M020
silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVBZINC OXIDE AND HOMOSALATEOneKind.25d739bc43-d76e-9258-e053-2a95a90a3d2c2025-06-12WarningsExact identifier
application number: M020
ULTRA SHEER DAILY DEFENSE FACIAL SPF 18HOMOSALATE, OCTISALATE, AND AVOBENZONEAndalou naturals0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f2025-06-11WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374e770f-75b5-08d0-e063-6394a90adf922025-06-11WarningsExact identifier
application number: M020
Reflecting Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEHelande, LLC3750f04b-7f9f-8793-e063-6294a90a91432025-06-11WarningsExact identifier
application number: M020
Vitamin C BB Beauty Balm Sheer Tint SFP 30ZINC OXIDEAndalou naturalsf423b484-2119-4c95-a0da-77bcd07303eb2025-06-11WarningsExact identifier
application number: M020
Perfecting BB Beauty Balm Natural Tint SPF 30ZINC OXIDEAndalou naturals16ca3790-9973-4a04-a43c-e0f7b384f1472025-06-11WarningsExact identifier
application number: M020
SOME BY MI V10 HYAL LIP SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATEPERENNEBELL Co., Ltd.3690af2b-fe22-3a9a-e063-6294a90a709d2025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEPPacifica Beauty, LLC373901f7-0e32-0f32-e063-6394a90abe252025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TANPacifica Beauty, LLC37397b96-ef14-9098-e063-6294a90aafc92025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHTPacifica Beauty, LLC373aba7c-2ae1-8726-e063-6294a90ae3d82025-06-10WarningsExact identifier
application number: M020
Zinc OxidePACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUMPacifica Beauty, LLC373c29b9-2f75-9777-e063-6394a90a68a62025-06-10WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences374395ea-ab91-de70-e063-6394a90aec562025-06-10WarningsExact identifier
application number: M020
ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30ZINC OXIDEAndalou naturalsaa689e82-6512-46d8-aec9-269f9348d3f82025-06-09WarningsExact identifier
application number: M020
ALLIES OF SKIN The One SPF-50 Invisible SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.36e1c61c-33ab-4a5d-853d-119c29632b082025-06-09WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTION STITANIUM DIOXIDE AND ZINC OXIDEShiseido Americas Corporationb2fae1ba-67fe-48ef-b31f-62db343499612025-06-09WarningsExact identifier
application number: M020
Olay Super Cream with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company372819f1-0813-2cd5-e063-6294a90ac5bf2025-06-09WarningsExact identifier
application number: M020
Naturium Phyto-Glow Lip Balm SPF 45-ClearAVOBENZONE, HOMOSALATE, OCTISALATEe.l.f. Cosmetics, Inc.3806e2f2-ffd1-6d69-e063-6394a90acb442025-06-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0240-413630024004200 mL in 1 CAN (13630-0240-4) 200 ml2022-03-070000-00-00NoNoCurrent