Home NDC 13630-0175-4 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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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 116 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c043e0-fd6c-5f7a-e063-6294a90a8899 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0c1ca-80a8-9d37-e063-6294a90a824f 2025-12-16 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ESTHETIC ACADEMY LLC 36c0f5df-6bfb-3c0d-e063-6294a90a2e5f 2025-12-16 Exact identifier application number: M020 Daily Protect Mineral Sunscreen ZINC OXIDE SARAH'S 4617beb7-381e-8994-e063-6394a90a14b5 2025-12-16 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT ENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDE Shiseido Americas Corporation 8db9f5e0-a8d6-4872-b4c6-cb92c43d25c2 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation 18ed9b7f-bdbe-45d7-a38c-6d065080ae99 2025-12-16 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE FOR BODY N ENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Shiseido Americas Corporation a2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c 2025-12-16 Warnings Exact identifier application number: M020 b.tan Beach Please SPF 7 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Marque of Brands Americas, LLC bdc07d83-a34f-5262-e053-2995a90acfc3 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 461910bd-1f74-f99e-e063-6394a90ae30e 2025-12-16 Warnings Exact identifier application number: M020 Daily Protect Tinted Mineral Sunscreen ZINC OXIDE SARAH'S 4619b08f-3e63-25aa-e063-6294a90a78d7 2025-12-16 Warnings Exact identifier application number: M020 meg ALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48 Meg Cosmetics Inc 4526bacf-6451-b297-e063-6294a90af71a 2025-12-16 Warnings Exact identifier application number: M020 Total Eye 3-In-1 Renewal Therapy SPF 35 TITANIUM DIOXIDE AND ZINC OXIDE Colorescience 4b116cc4-94d2-4bfc-b7f9-5f486a194c6c 2025-12-16 Warnings Exact identifier application number: M020 Daily SPF Facial SunscreenLotion Broad Spectrum SPF 32 ZINC OXIDE Onekind.25 c11197f4-cee0-04b3-e053-2995a90a1ba8 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium Deep ZINC OXIDE Crunchi, LLC. 69618265-2ebb-4cdc-a28f-e36c07fe5b8f 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Medium ZINC OXIDE Crunchi, LLC. 23248bc3-1b82-443a-b38a-df7f0efb5d2a 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light ZINC OXIDE Crunchi, LLC. cf4039f5-00ee-4227-a3dc-61995c800135 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Body Sunscreen SPF 30 ZINC OXIDE Crunchi, LLC. 227f5a41-8c3c-492d-947f-e2b046208bca 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Tinted Sunscreen SPF 30 Light Medium ZINC OXIDE Crunchi, LLC. 5b3f2766-065b-4817-a5ff-bd1c7882bfc9 2025-12-15 Warnings Exact identifier application number: M020 Crunchi Sunlight Daily Facial Sunscreen SPF 30 ZINC OXIDE Cruchi, LLC. 4f3bcfa0-e43e-4284-afaa-6488ddd749f0 2025-12-15 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Essential Brazilian Spa LLC 3543a22c-34d5-e572-e063-6394a90ad579 2025-12-15 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13630-0175-4 13630017504 198 g in 1 CAN (13630-0175-4) 198 g 2019-11-13 2023-08-31 No No Current