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 297 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY ZINC OXIDE Rms organics LLC 1a1aebea-ed0c-ac92-e063-6294a90aeae6 2024-06-04 Warnings Exact identifier application number: M020 Brush On Block SPF 30 Mineral Powder Translucent Zinc Only ZINC OXIDE SPF Ventures, LLC 1a1bf910-f1bc-bd75-e063-6294a90a663f 2024-06-04 Warnings Exact identifier application number: M020 PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals, LTD 0b62062d-b77e-4e6c-b3ab-b35ab24db7cb 2024-06-04 Warnings Exact identifier application number: M020 Protectif Deep Tint ZINC OXIDE AND TITANIUM DIOXIDE Derma Research Group Inc. 19b19023-1340-6609-e063-6394a90a6eaf 2024-05-30 Warnings Exact identifier application number: M020 EltaMD UV Sport SPF50 ZINC OXIDE, OCTINOXATE AND OCTISALATE SUNSCREEN CP Skin Health Group, Inc. dffc3fde-5b6e-4a62-8289-9733be43455b 2024-05-30 Warnings Exact identifier application number: M020 Vacation by Vacation Scent and Shimmer Duo AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Vacation Inc. aef8388f-84bb-4e2b-8ae2-aa64f415a632 2024-05-28 Warnings Exact identifier application number: M020 SPF50 Sunscreen Cariposa ZINC OXIDE Talent Brands Company LLC 1938fa13-875a-140e-e063-6294a90a5514 2024-05-24 Warnings Exact identifier application number: M020 Derma E Vitamin C Weightless Moisturizer SPF 45 ZINC OXIDE derma e a3b404a6-e4b1-4c08-a8ef-77446dd2e411 2024-05-24 Warnings Exact identifier application number: M020 COOLA Classic Liplux Lip Balm SPF 30 Original AVOBENZONE, OCTISALATE, OCTOCRYLENE COOLA, LLC eeb420f0-c92f-0d96-e053-2a95a90afe36 2024-05-22 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee2842c3-65e0-3904-e053-2a95a90aabff 2024-05-22 Warnings Exact identifier application number: M020 COOLA Mineral Liplux Lip Balm SPF 30 Firecracker TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee026a1c-885b-256f-e053-2a95a90af564 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ec96dee8-85e8-3147-e053-2995a90aaf53 2024-05-22 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess TITANIUM DIOXIDE COOLA, LLC eeb406c6-a543-379a-e053-2995a90a4998 2024-05-22 Warnings Exact identifier application number: M020 COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose TITANIUM DIOXIDE COOLA, LLC ee01642f-478e-b307-e053-2a95a90a7d81 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 30 Mineral Sunscreen Coco Mango ZINC OXIDE COOLA, LLC eca9ae89-19dc-516d-e053-2995a90a4698 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Matte Untinted Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ecabcc89-fb09-41a9-e053-2995a90a8b31 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Matte Tinted Face SPF 30 TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC ee018c21-dca7-28aa-e053-2a95a90a3bdb 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic SPF 30 Mineral Sunscreen Citrus Cooler ZINC OXIDE COOLA, LLC ecaad342-1873-60bc-e053-2995a90a5952 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Shimmer SPF 30 Golden Daze TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC eeb70034-0f8d-a46d-e053-2a95a90a8130 2024-05-22 Warnings Exact identifier application number: M020 Bare Republic Mineral Shimmer SPF 30 Diamond Dust TITANIUM DIOXIDE, ZINC OXIDE COOLA, LLC eec83ecb-d0ab-7857-e053-2995a90a40ed 2024-05-22 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