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 247 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc b137b3d0-212b-440a-b158-62ace4b4eff3 2024-12-30 Warnings Exact identifier application number: M020 SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products Inc 3a6db7d3-6c59-4633-a97e-1c03127246d3 2024-12-30 Warnings Exact identifier application number: M020 Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 Sunscreen OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc df62e1c2-ce72-4ded-8985-156dce9ff41d 2024-12-28 Warnings Exact identifier application number: M020 LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE L'Oreal USA Products Inc 02dddfc5-61e6-433b-8d6d-a17bf3fc8ed6 2024-12-28 Warnings Exact identifier application number: M020 Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE Cosmetique Active Production 229eef79-39ae-4395-8100-64d1ece960d2 2024-12-28 Warnings Exact identifier application number: M020 COOLA Mineral Sun Silk Creme Sunscreen SPF 30 ZINC OXIDE COOLA LLC bb9dd9a9-ec01-4e94-9172-3a72e68a417a 2024-12-27 Warnings Exact identifier application number: M020 Bare Republic Mineral SPF 50 ZINC OXIDE COOLA LLC 6a0db9da-ee45-4ab7-80de-4bf189efe75f 2024-12-27 Warnings Exact identifier application number: M020 COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50 AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE COOLA LLC 9a397a2c-4734-4dae-93dd-15c68e6c297d 2024-12-27 Warnings Exact identifier application number: M020 Refreshing Water Hydration Stick SPF 50 AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE COOLA LLC 6da037f8-bedb-467a-b534-e44752120f2c 2024-12-27 Warnings Exact identifier application number: M020 Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE NSE Products, Inc. 649a9c28-bfd4-404c-90d5-5d0ea8c7b645 2024-12-27 Warnings Exact identifier application number: M020 Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen TITANIUM DIOXIDE L'Oreal USA Products Inc 87496037-36ca-4c5f-973f-46626cf4096e 2024-12-27 Warnings Exact identifier application number: M020 PORESCREEN SPF40 ZINC OXIDE Dermalogica, LLC. 37a7362a-b251-4d3a-a957-65d8f338fa12 2024-12-27 Warnings Exact identifier application number: M020 COOLA Classic Face Sunscreen Fragrance-Free SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA LLC 12ff4689-f7e2-49db-8848-608c61b41ef0 2024-12-27 Warnings Exact identifier application number: M020 NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT ZINC OXIDE Bentley Laboratories, LLC 6edd51e5-1c42-4e66-b5ca-abfea2dad8f8 2024-12-27 Warnings Exact identifier application number: M020 Tone Control Morning Cream SPF 15 OCTOCRYLENE AND OCTISALATE CREAM Bentley Laboratories, LLC b4e3cd1c-ae42-4995-a314-96d24d328e41 2024-12-27 Warnings Exact identifier application number: M020 ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) ZINC OXIDE ZO Skin Health, Inc. be25489e-c3bf-77c5-e053-2a95a90a30de 2024-12-27 Warnings Exact identifier application number: M020 COOLA Classic Body Sunscreen Tropical Coconut SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COOLA LLC 55ad5d2f-a855-491e-a287-13689f8abff1 2024-12-27 Warnings Exact identifier application number: M020 RODAN and FIELDS UNBLEMISH TITANIUM DIOXIDE, ZINC OXIDE Bentley Laboratories, LLC 2b3b6b62-364f-4aba-8024-3a73752b4c56 2024-12-27 Warnings Exact identifier application number: M020 Powerbright Moisturizer SPF 50 OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATE Dermalogica, LLC. 02c731ee-c5cb-4158-9b1f-e826593c3526 2024-12-27 Warnings Exact identifier application number: M020 INVISIBLE PHYSICAL DEFENSE SPF30 ZINC OXIDE Dermalogica, Inc. 2e5e6861-25ea-4605-8e59-41d852c002b7 2024-12-27 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