Australian Gold

Product NDC
13630-0167
11-digit product format
136300167
Labeler code
13630
Product ID
13630-0167_e64d027f-2258-a8c5-e053-2a95a90ae1b0
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
2019-05-06
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
26 mg/mL; mg/mL; mg/mL; mg/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 productproduct13630-0167DDiscontinued by firm2026-10-16
excluded packagepackage13630-016713630-0167-4DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13630-0167-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13630-0167-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13630-0167-4DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13630-0167-4DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13630-0167-4DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13630-0167-4DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13630-0167-4DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13630-0167-4DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13630-0167-4DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13630-0167-4DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13630-0167-4DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13630-0167-4DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13630-0167-4IInactivated by FDA1332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

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 103 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREENZINC OXIDE, TITANIUM DIOXIDELABORATOIRES DERMO-COSMETIK INC.468c90d7-3b9e-1641-e063-6394a90a928c2025-12-22WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC3e65ec1a-0ed9-433d-8da9-a6cb618299112025-12-22WarningsExact identifier
application number: M020
Sun Shades Sunscreen Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMelaleuca Inc.1f982f03-9542-29f9-e063-6294a90a959c2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GLOW GETTER SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.ca99b8c4-6778-43dc-bdd5-ca4a470860a02025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO MINERAL DEFENSE SPORT SUPERFRUIT VITAMIN C PLUS ALOE SHEER SUNSCREEN MIST SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f810843b-5a4d-6cbc-e053-6294a90ac9e32025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 NATURALLY SCENTEDZINC OXIDESOLARA SUNCARE, INC.7a5644b9-4368-4e9a-aa22-b3307acf43cc2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT CERAMIDE SPF-30ZINC OXIDESOLARA SUNCARE, INC.cbf9c715-2d45-4c1b-b58f-42795722821c2025-12-22WarningsExact identifier
application number: M020
SPF 50 Baby Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc4690d89b-ae61-2ed5-e063-6294a90a743f2025-12-22WarningsExact identifier
application number: M020
MINERAL DEFENSE SPORT ANTIOXIDANT FACE SUNSCREEN SPF-50ZINC OXIDESOLARA SUNCARE, INC.f5242c7d-09e1-4141-8de1-a89bd7981ca62025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - TIME TRAVELER SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.f7ad1b52-6d9d-4a12-a6ab-6584ffc39cc92025-12-22WarningsExact identifier
application number: M020
Go Daily Defense Soothing Mineral Face Sunscreen SPF-30ZINC OXIDESOLARA SUNCARE, INC.fd040893-b1e5-783f-e053-6294a90ac2162025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - CLEAN FREAK SPF-30 UNSCENTEDZINC OXIDESOLARA SUNCARE, INC.0fc8fadf-69fc-40ad-b4ca-d96dd2b30f952025-12-22WarningsExact identifier
application number: M020
GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50ZINC OXIDESOLARA SUNCARE, INC.f3bb46e8-a9a5-b184-e053-2995a90afca72025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - POUT PROTECTOR SPF-15ZINC OXIDESOLARA SUNCARE, INC.ab6a326d-3b93-4122-a9f2-05e8203d31ef2025-12-22WarningsExact identifier
application number: M020
SOLARA SUNCARE - FORTUNE TELLER SPF-30ZINC OXIDESOLARA SUNCARE, INC.f434de33-5da8-57ef-e053-2a95a90a85022025-12-22WarningsExact identifier
application number: M020
SPF 50 Kids Sunscreen EquateAVOBENZONE, HOMOSALATE, OCTOCRYLENEWalmart Inc46919f43-2dee-57b1-e063-6294a90a15eb2025-12-22WarningsExact identifier
application number: M020
SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWalmart Inc46919f45-e3f3-4ed0-e063-6294a90a98352025-12-22WarningsExact identifier
application number: M020
Sugargirl Glowy SPF 30 Face Screen daybreak Shimmer Sunscreen for the faceHOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE, AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.451bb734-d54d-e24e-e063-6394a90a1adb2025-12-21WarningsExact identifier
application number: M020
CabanaClear Illuminating SPF 50HOMOSALATE, OCTISALATE, AVOBENZONENAKED SUNDAYS PTY LTD47d1a39e-f645-c33d-e063-6394a90ad1ef2025-12-21WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13630-0167-413630016704152 g in 1 CAN (13630-0167-4) 152 g2019-05-060000-00-00NoNoCurrent