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 279 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kroger Dry Oil Tanning Sunscreen Broad Spectrum SPF 15 Reef Friendly AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE THE KROGER COMPANY c706aaf0-a978-7848-e053-2995a90a0aca 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultimate Sheer Sun Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC c51029f4-ede0-08ef-e053-2995a90aecaf 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT CONTINUOUS BROAD SPECTRUM SPF 30 AVOBENZONE, HOMOSALATE, OCTOCRYLENE, TOPCO ASSOCIATES LLC c8af028e-9d68-4023-e053-2995a90ad18a 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY ULTRA PROTECTION SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c5601d22-2353-7319-e053-2a95a90a16c0 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY CONTINUOUS BROAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c8c12a5a-59f5-6515-e053-2995a90a58f7 2024-10-15 Warnings Exact identifier application number: M020 Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 55 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC c6268778-8dcc-24b6-e053-2995a90acf03 2024-10-15 Warnings Exact identifier application number: M020 ndc (product): 36800-167 TopCare Everyday Sport Sun SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f0de2999-f12b-89b1-e053-2a95a90ac610 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY MINERAL SUNSCREEN ZINC OXIDE SPF 50 ZINC OXIDE TOPCO ASSOCIATES LLC d501a94e-3bcd-d8e4-e053-2a95a90a33b0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Kids Mineral Sunscreen ZINC OXIDE TOPCO ASSOCIATES LLC dbee42c8-9cae-7a81-e053-2a95a90a2329 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Sun Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f12c09b1-8ffe-4933-e053-2995a90a434f 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Zinc Oxide SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC dbf03882-ab1a-9805-e053-2995a90a7109 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Mineral Sunscreen Continuous Broad Spectrum SPF 50 Reef-Conscious Formula TITANIUM DIOXIDE, ZINC OXIDE TOPCO ASSOCIATES LLC f14f43e6-ee57-5495-e053-2a95a90a4011 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Sport Continuous Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC f31ea60e-1f52-c55f-e053-2a95a90afe64 2024-10-15 Warnings Exact identifier application number: M020 Topco Topcare Everyday Mineral Sunscreen Continuous SPF 30 ZINC OXIDE TOPCO ASSOCIATES LLC f71e019b-392a-f8eb-e053-6394a90a871e 2024-10-15 Warnings Exact identifier application number: M020 TOPCARE EVERYDAY SPORT SPF 70 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE TOPCO ASSOCIATES LLC a5b06600-f2b0-6d9b-e053-2995a90a59f0 2024-10-15 Warnings Exact identifier application number: M020 TopCare Everyday Ultra Protection Sun SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE TOPCO ASSOCIATES LLC f41d4c46-7998-afe6-e053-2995a90ab361 2024-10-15 Warnings Exact identifier application number: M020 TOPCO TOPCARE EVERYDAY BABY PROTECTION SUN SPF 50 OCTISALATE, ZINC OXIDE TOPCO ASSOCIATES LLC f71c9060-3daf-e1be-e053-6294a90a4f91 2024-10-15 Warnings Exact identifier application number: M020 MINERAL SUNSCREEN SPF 50 ZINC OXIDE, TITANIUM DIOXIDE TOPCO ASSOCIATES LLC bfe076fa-f21f-2c46-e053-2a95a90acee4 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Mineral Sunscreen Stick ZINC OXIDE H.E.B. f58f0199-bf22-2197-e053-2995a90ae64f 2024-10-15 Warnings Exact identifier application number: M020 HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented ZINC OXIDE H.E.B. f58d328c-8b30-b4d4-e053-2a95a90adb59 2024-10-15 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