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 firm2026-10-23

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 · 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 162 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YAY NOVELTY ALL-IN-ONETITANIUM DIOXIDE, ZINC OXIDEYAY Noveltyfb833158-d0d8-de7f-e053-6294a90adc5a2025-11-14WarningsExact identifier
application number: M020
Thu Brule Free Spirit Correct and ProtectTITANIUM DIOXIDE, ZINC OXIDELaughing Buddha LLC258a4f97-d811-0521-e063-6394a90aaf3b2025-11-14WarningsExact identifier
application number: M020
Alpha-H Total EclipseTITANIUM DIOXIDE, ZINC OXIDEAlpha-Hfc8a4efe-7d5e-5f44-e053-6394a90a80aa2025-11-14WarningsExact identifier
application number: M020
Svens Everyday Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESvens, Inc912170ae-124c-5eb9-e053-2995a90a0ba32025-11-14WarningsExact identifier
application number: M020
Wander Beauty Pack Up and Glow PrimingTITANIUM DIOXIDE, ZINC OXIDEWander Beauty3d844efc-091c-9a9b-e063-6294a90aee7c2025-11-14WarningsExact identifier
application number: M020
Baby Bare Republic Mineral SunscreenZINC OXIDECOOLA, LLCb292d1a9-7ff8-0faf-e053-2995a90ae3422025-11-14WarningsExact identifier
application number: M020
Aspen Islanders Sheer Mineral SportZINC OXIDEAspen Islanders LLC0fcb2adf-71c9-3369-e063-6294a90aa8062025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE MALON DAZEBy the Beach Suncare LLC4391728b-dfe7-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CITRUS CRUSHBy the Beach Suncare LLC43918d25-e947-5e17-e063-6394a90ada7c2025-11-14WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE CANDY CLOUDSBy the Beach Suncare LLC4391728b-dfe8-3ffb-e063-6394a90a240e2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Balance and ClearZINC OXIDESunsolve MD Inc26f3595d-adef-a8a5-e063-6394a90adfd42025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Detox and ShieldZINC OXIDESunsolve MD Inc26f3886b-a3a5-c9b7-e063-6394a90af6c32025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Amber 002ZINC OXIDESunsolve MD Inc26e00001-9c68-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Agate 003ZINC OXIDESunsolve MD Inc26e00001-9c6f-0734-e063-6394a90a17872025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Bronzite 004ZINC OXIDESunsolve MD Inc26e13356-9ab5-246a-e063-6394a90a2a702025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Onyx 006ZINC OXIDESunsolve MD Inc26e16b5e-dd2e-6fb8-e063-6394a90a6a7f2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Calm and RevitalizeZINC OXIDESunsolve MD Inc26f3f534-a305-3530-e063-6394a90a75e12025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Mineral Shade Garnet 005ZINC OXIDESunsolve MD Inc26e1508f-d386-329b-e063-6394a90a0a982025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Firm and ReplenishZINC OXIDESunsolve MD Inc26f3417b-9ea4-e577-e063-6294a90ae53c2025-11-14WarningsExact identifier
application number: M020
Sunsolve MD Correct and FadeZINC OXIDESunsolve MD Inc26f3ad9f-f8ca-05d4-e063-6394a90ad5c42025-11-14WarningsExact 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