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 FDA2026-10-21
excluded packagepackage13630-024013630-0240-4IInactivated by FDA2026-10-21

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 157 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EcoZinc Natural Mineral Sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED386e23ec-7618-f42c-e063-6394a90a595d2025-11-27WarningsExact identifier
application number: M020
KOVR Military grade sunscreen for MenZINC OXIDEACTIVE LIFE INCc9fbbc6e-6284-4308-89a3-98300c3a03202025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sensitive Mineral SPF 50ZINC OXIDEThe Hain Celestial Group, Inc.4484b16f-f29a-60cc-e063-6294a90a2b9d2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF50ZINC OXIDEThe Hain Celestial Group, Inc.0cf9c4b9-8e85-980c-e063-6394a90a9e7e2025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sensitive Mineral SPF 30ZINC OXIDEThe Hain Celestial Group, Inc.44867882-d9c1-7389-e063-6294a90a7f772025-11-26WarningsExact identifier
application number: M020
Alba Botanica Sheer Mineral SPF30ZINC OXIDEThe Hain Celestial Group, Inc.0cf9361f-f292-6429-e063-6294a90add0e2025-11-26WarningsExact identifier
application number: M020
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.ec8386f2-9cb7-40f4-e053-2995a90ac2d82025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.330a9f2e-7ce1-f83f-e063-6394a90a184a2025-11-26WarningsExact identifier
application number: M020
WOODSLEEP Tallow SunscreenTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.33cdde09-e7ee-e003-e063-6394a90a87622025-11-26WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44718c3c-b081-bcfb-e063-6394a90a37862025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472cc1e-6b34-388b-e063-6394a90ac7b62025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4472ef69-8992-fcab-e063-6294a90a6b902025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company44732f89-8ac3-8c5d-e063-6394a90aba732025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company447347d6-b8a3-7338-e063-6294a90abbf92025-11-25WarningsExact identifier
application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company4473c4cc-f8b5-4a92-e063-6394a90ae6902025-11-25WarningsExact identifier
application number: M020
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
application number: M020
Safe Sea SPF 50 MineralZINC OXIDENidaria Technology Ltd.f6cf9454-552b-486e-a38b-ab3c183b24a12025-11-24WarningsExact identifier
application number: M020
Safe Sea SPF 30ZINC OXIDENidaria Technology Ltd.91bf07ed-0be4-43c9-b5f3-4e8eb892bca52025-11-24WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15OCTINOXATE AND ZINC OXIDEThe Procter & Gamble Manufacturing Company5904baa8-3070-1d77-e053-2a91aa0a68522025-11-24WarningsExact identifier
application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact 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