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 321 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB Cream ZINC OXIDE Gin Amber Beauty LLC 32f48fe4-5788-449e-9ed8-9cd8b2ecc1c0 2023-11-14 Warnings Exact identifier application number: M020 Private Label SPF 50 80 min Water Resistant HOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC 8849fa88-24c8-410d-b16e-60da38288f98 2023-11-14 Warnings Exact identifier application number: M020 Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 ZINC OXIDE Galderma Laboratories, L.P. 0d09b812-b3ca-4214-bed7-7e21ee3288b7 2023-11-14 Warnings Exact identifier application number: M020 DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15 AVOBENZONE, HOMOSALATE, OCTISALATE ESTEE LAUDER INC 0a0bfe4a-53b6-5b7c-e063-6394a90a23ec 2023-11-13 Warnings Exact identifier application number: M020 Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect Repellent AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BULLFROG BRANDS, LLC. f70b39c6-9f40-f5c1-e053-6394a90a1d43 2023-11-13 Warnings Exact identifier application number: M020 Bull Frog SPF 50 AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00% Bullfrog Brands, LLC c90fc29e-d9fe-a6c9-e053-2995a90a69b3 2023-11-13 Warnings Exact identifier application number: M020 Tropical Sands, SPF-50 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 493551d0-10a0-3d78-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 494a7886-d677-1648-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 Tropical Sands SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. ab691543-e37a-487a-912e-56d2e0e4d30a 2023-11-11 Warnings Exact identifier application number: M020 LBri Pure nNatural Oil Free Moisturizer OCTINOXATE, AVOBENZONE, OCTISALATE L'Bri Health & Beauty 47f6ab9e-fa47-496a-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 PURE HAVEN BODY SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Pure haven, LLC 6f298fcd-8a97-8f66-e053-2991aa0adb10 2023-11-11 Warnings Exact identifier application number: M020 Sunstation All-Natural SPF 30 Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Sunstation USA, LLC 499d366a-a7f1-6070-e054-00144ff88e88 2023-11-11 Warnings Exact identifier application number: M020 PURE HAVEN Face Sunscreen SPF-30 ZINC OXIDE Pure Haven, LLC 1fff88a0-4d23-4cd7-872e-1a0b8c680342 2023-11-11 Warnings Exact identifier application number: M020 Pure Haven Essentials TITANIUM DIOXIDE, ZINC OXIDE Pure Haven LLC 4bccc017-266d-11ce-e054-00144ff8d46c 2023-11-11 Warnings Exact identifier application number: M020 No BS SPF20 Moisturizer OCTINOXATE, AVOBENZONE, OCTOCRYLENE Product Management LLC 690f68fa-d110-4a75-9a14-04aac1be4584 2023-11-11 Warnings Exact identifier application number: M020 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Kapa'ihi, Inc 66e5eb1b-4ef0-459d-8428-b3e2f221bc85 2023-11-11 Warnings Exact identifier application number: M020 Sea Star Sparkle SPF-50 PARTY CAKE OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MJ Products Association, LLC 8cfaf1b6-0f25-4770-9760-2440b2c153b7 2023-11-11 Warnings Exact identifier application number: M020 Sea Star Sparkle SPF-50 VERY BERRY OCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE MJ Products Association, LLC 88c403ea-7c78-423e-b05e-1e17c21c5a53 2023-11-11 Warnings Exact identifier application number: M020 FITGLOW Vita Shield Hyaluronic Primer SPF-30 ZINC OXIDE FITGLOW BEAUTY LLC b9ba7783-74ca-4736-8a60-169215859047 2023-11-11 Warnings Exact identifier application number: M020 BLUE MONARCH Tinted SPF-50 (Rose Gold) ZINC OXIDE Blue Monarch, LLC 9ba00a03-1015-4946-8c9b-5ef377a32e4b 2023-11-11 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