Australian Gold

Product NDC
13630-0175
Requested package NDC
13630-0175-4
11-digit product format
136300175
Labeler code
13630
Product ID
13630-0175_e1f79271-4a2d-249b-e053-2a95a90a185e
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
2019-11-13
Marketing end
2023-08-31
Substance
AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength
2 g/100g; g/100g; g/100g
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 packagepackage13630-017513630-0175-4DDiscontinued by firm2026-10-16

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.

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 48 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simple Mineral Sunscreen SPF 50ZINC OXIDESimple Sunscreen LLCc38cb4fa-8b8d-4c2d-9c32-301e120db1a12026-04-06WarningsExact identifier
application number: M020
Badger SPF 50 Adventure Sport Mineral Sunscreen CreamZINC OXIDEW.S. Badger Company, Inc.2a96c423-f4ad-0f07-e063-6394a90a39f82026-04-06WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC03fce792-bcbb-4848-bc87-8913ecbe07862026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC8937705d-b745-4b8c-bf9b-89e64a1e52b12026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab6773f-00e1-897a-e063-6294a90ab0b82026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEGuthy-Renker LLCeb1a9b67-b9e2-41f8-bc6d-df94b6a33ab82026-04-06WarningsExact identifier
application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUMHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENETIRTIR USA Inc.4ec04105-e54f-a82e-e063-6394a90a6c5a2026-04-05WarningsExact identifier
application number: M020
PRVWORA Ultra Defense SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECellarkbio Inc.50cf1d88-3e7e-47b7-816a-3d579bde0a6a2026-04-04WarningsExact identifier
application number: M020
EltaMD UV Shield SPF45ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.7c49f971-d425-4be9-a665-5cd218b7f9452026-04-03WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
application number: M020
Vacation SPF 30 ClassicSprayAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.da43d71d-733b-5700-e053-2a95a90a5dca2026-04-03WarningsExact identifier
application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30ZINC OXIDEAllure Labs4e93e64a-97ab-e0a5-e063-6294a90ad9502026-04-03WarningsExact identifier
application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
application number: M020
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
application number: M020
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
application number: M020
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTEDZINC OXIDEFallien Cosmeceuticals, LTD4e7c4702-5707-6c3e-e063-6394a90a05fd2026-04-02WarningsExact identifier
application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light MediumZINC OXIDEIlia, Inc.4e7cc73c-d6c9-ecb0-e063-6394a90a922c2026-04-02WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0175-413630017504198 g in 1 CAN (13630-0175-4) 198 g2019-11-132023-08-31NoNoCurrent