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 268 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN TITANIUM DIOXIDE ORGANIC & SUSTAINABLE BEAUTY d4f30d95-4a3f-49ad-817e-faa86fca5018 2024-11-07 Warnings Exact identifier application number: M020 Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion ZINC OXIDE SEORIN COMPANY Co., Ltd. 26407b83-b417-6450-e063-6294a90ad2b1 2024-11-06 Warnings Exact identifier application number: M020 e.l.f. Holy Hydration Face Cream SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE e.l.f. Cosmetics, Inc b7898d65-df86-580a-e053-2a95a90a5b1b 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Fragrance Free SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acda604c-27cf-d500-e053-2995a90a5d65 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Fragrance Free SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acb92160-1749-d51b-e053-2995a90a9e87 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Toasted Coconut Lip Balm with SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acb8513e-723b-b7d6-e053-2995a90aed52 2024-11-06 Warnings Exact identifier application number: M020 Bondi Sands Fragrance Free Face SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE BONDI SANDS (USA) INC. acda9863-ad9f-e430-e053-2995a90a69a6 2024-11-06 Warnings Exact identifier application number: M020 Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE SEORIN COMPANY Co., Ltd. 26442417-f238-1fc3-e063-6394a90a6f82 2024-11-06 Warnings Exact identifier application number: M020 Avene Mineral Sunscreen Face and Body ZINC OXIDE Pierre Fabre USA Inc. fb5b1e94-bed3-8486-e053-6294a90a3a84 2024-11-06 Warnings Exact identifier application number: M020 Avene Cleanance Mattifying SPF 30 ZINC OXIDE Pierre Fabre USA Inc. 2644f545-0625-7858-e063-6394a90a5963 2024-11-06 Warnings Exact identifier application number: M020 SPF30 CALENDULA SUNSCREEN TITANIUM DIOXIDE ORGANIC & SUSTAINABLE BEAUTY 64580be7-868c-40fb-b7b8-840b417b25d3 2024-11-06 Warnings Exact identifier application number: M020 KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREEN TITANIUM DIOXIDE ORGANIC & SUSTAINABLE BEAUTY 20ebe264-2f79-4eef-b83d-3f09a3ca2898 2024-11-06 Warnings Exact identifier application number: M020 Cream Oil Sunscreen ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN Owen Biosciences, Inc. b2ccdfea-1c27-42af-b9d8-752e9f91ae87 2024-11-05 Warnings Exact identifier application number: M020 Vivant Day Treatment SPF 15 OCTINOXATE 7.50% OCTISALATE 5.00% Vivant Pharmaceuticals, LLC 10a95d0a-366f-0611-e063-6294a90abb44 2024-11-05 Warnings Exact identifier application number: M020 ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. 1560a6b6-8d4a-6942-e063-6294a90a4a44 2024-11-04 Warnings Exact identifier application number: M020 Bali Body Watermelon Tanning Oil SPF 15 AVOBENZONE, OCTISALATE, OCTOCRYLENE Bali Body Pty Ltd 07d96576-fd78-acf3-e063-6394a90af45b 2024-11-03 Warnings Exact identifier application number: M020 Neutrogena Mineral Ultra Sheer Dry-Touch Face and Body Sunscreen Broad Spectrum UVA-UVB SPF 50 ZINC OXIDE Kenvue Brands LLC 8f34c1f6-51fe-4719-ba1f-1e23c05e937b 2024-11-01 Warnings Exact identifier application number: M020 Byoma Moisturizing Sunscreen SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE BYOMA LIMITED 25de7939-3b18-7f9e-e063-6394a90a23a9 2024-11-01 Warnings Exact identifier application number: M020 Dr Edward Krulig New Melan Sunblock SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE KRULIG INTERNATIONAL, INC 21c301d2-b283-40e1-bf26-b4bdde278247 2024-10-31 Warnings Exact identifier application number: M020 ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50 ZINC OXIDE ZO Skin Health, Inc. f218c158-19aa-ab90-e053-2a95a90aaef3 2024-10-31 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