Home NDC 36800-167 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55
Product NDC 36800-167
11-digit product format 368000167
Labeler code 36800
Product ID 36800-167_2487df86-039b-4d33-e063-6394a90acb50
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler TOPCO ASSOCIATES LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-07-24
Substance OCTOCRYLENE; OCTISALATE; HOMOSALATE; AVOBENZONE
Active strength 70; 50; 100; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 36800-167-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 36800-167-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 36800-167-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 36800-167-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 36800-167-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 36800-167-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 36800-167-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 36800-167-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 36800-167-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 36800-167-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 36800-167-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 36800-167-08 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTOCRYLENE 70 mg/mL OCTISALATE 50 mg/mL HOMOSALATE 100 mg/mL AVOBENZONE 30 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-167-09 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 89 mL in 1 TUBE LOTION 89 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-167 TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 55 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [TOPCO ASSOCIATES LLC] 2 Current NDC, Legacy NDC, 1 package rows 20241017_c6268778-8dcc-24b6-e053-2995a90acf03.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 313 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coola Bare Republic Mineral Body Gel-Lotion SPF 30 ZINC OXIDE 18.2% COOLA LLC d745d12e-8741-4bf2-89ec-c6f72a8d548b 2023-12-20 Warnings Exact identifier application number: M020 COOLA Classic Body Sunscreen SPF 70 - Peach Blossom AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA LLC 6efa0d9f-0ff3-4b2f-9587-9630261bcbd1 2023-12-20 Warnings Exact identifier application number: M020 sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen light TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc. b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc 2023-12-20 Warnings Exact identifier application number: M020 Coola Bare Republic Mineral Face Gel-Lotion SPF 30 ZINC OXIDE 18.2% COOLA LLC ad1614d4-5421-473d-a1e8-0ff18491df77 2023-12-20 Warnings Exact identifier application number: M020 COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Bentley Laboratories, LLC 4e0e426d-f037-428f-98f2-2d3e945bd040 2023-12-19 Warnings Exact identifier application number: M020 COOLA Classic Body Sunscreen Fragrance-Free SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Bentley Laboratories, LLC 57f2fdeb-2abc-4ad3-bb89-5faee883c0e5 2023-12-19 Warnings Exact identifier application number: M020 Baby Bare Republic Mineral Sunscreen SoftStick SPF 50 ZINC OXIDE COOLA LLC 1a603f62-86ec-4e66-a73f-718c5d012676 2023-12-19 Warnings Exact identifier application number: M020 COOLA Classic Body Sunscreen Pina Colada SPF 30 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Bentley Laboratories, LLC d508cef6-977f-4231-8c19-491569e99921 2023-12-19 Warnings Exact identifier application number: M020 Nudestix Daily Mineral Veil SPF 30 Tint - Hot ZINC OXIDE 15% Bentley Laboratories, LLC a9e7a203-52f0-4a67-b3ea-65ff0968ec18 2023-12-19 Warnings Exact identifier application number: M020 COOLA Refreshing Water Mist SPF 18 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Bentley Laboratories, LLC 658bf3fe-2246-40b6-8cb1-969bfdaffd1b 2023-12-19 Warnings Exact identifier application number: M020 Nudestix Daily Mineral Veil SPF 30 Tint Free - Cool ZINC OXIDE 15% Bentley Laboratories, LLC cd80661f-348c-4bfd-a85c-041db1a1d0f4 2023-12-19 Warnings Exact identifier application number: M020 Nudestix Daily Mineral Veil SPF 30 Tint - Warm ZINC OXIDE 15% Bentley Laboratories, LLC d5fd3fea-5dcf-42ef-927a-3b4a3e1ccff8 2023-12-19 Warnings Exact identifier application number: M020 foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutral TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc. f5d54e9d-4963-419a-a091-bdbd1decd2b8 2023-12-19 Warnings Exact identifier application number: M020 CHEVOURI Brightening Serum Broad Spectrum SPF-40 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CHE'VOURI LLC 5a93d5f9-9313-4194-8c39-c513f5a85853 2023-12-18 Warnings Exact identifier application number: M020 Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE SICOS ET CIE 9598949a-0dd6-4932-9dc8-354f9e10b601 2023-12-18 Warnings Exact identifier application number: M020 BB blur tinted moisturizer Broad Spectrum SPF 30 light TITANIUM DIOXIDE AND ZINC OXIDE Tarte, Inc. 207aaa0c-777f-4abd-96b7-64666eb87f53 2023-12-18 Warnings Exact identifier application number: M020 Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 Sunscreen OCTINOXATE AND TITANIUM DIOXIDE L'Oreal USA Products Inc 69e0d803-be76-4cc3-bdeb-b50401d5d6d4 2023-12-18 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep TITANIUM DIOXIDE AND ZINC OXIDE Cosmetique Active Production 8bdd63f7-2f67-4280-9484-d6c8e80ad9b9 2023-12-16 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium Deep TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 8ab49def-c9cd-489e-a936-467067a88940 2023-12-16 Warnings Exact identifier application number: M020 La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium Deep TITANIUM DIOXIDE AND ZINC OXIDE Cosmetique Active Production 0cb8f22d-2343-415e-9f16-1791567864a1 2023-12-16 Warnings 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 36800-167-09 36800016709 89 mL in 1 TUBE (36800-167-09) 89 ml 2019-07-24 0000-00-00 No No Current