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 213 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM Port Jervis Laboratories, Inc. 350cd329-8fe2-314f-e063-6394a90ac954 2025-05-13 Warnings Exact identifier application number: M020 Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30 ZINC OXIDE Lancer Skincare LLC 522a9158-2fd1-4634-adef-2ba84c86bcd7 2025-05-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Navajo Manufacturing Company Inc. 33f13aa4-9279-c251-e063-6294a90a2d67 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BS SPF 30 TINTED DEEP ZINC OXIDE Allure Labs 34f51ff4-541d-2b2e-e063-6394a90a39da 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Natural SPF 30 ZINC OXIDE Renu Laboratories, LLC e7035fcd-6894-3360-e053-2a95a90a6f1d 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Sport SPF ZINC SPF RENU LABORATORIES, LLC c9b48a9e-d69f-65a7-e053-2995a90a0baf 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP ZINC OXIDE Allure Labs 34f674c1-5d59-915a-e063-6394a90a6c2f 2025-05-12 Warnings Exact identifier application number: M020 Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE Meaningful Beauty, LLC f59fe019-569b-49ba-accf-fa4d356ce96b 2025-05-12 Warnings Exact identifier application number: M020 Cicatricure Gold Lift SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Genomma Lab USA 34cc5b3c-af36-e202-e063-6294a90a13a7 2025-05-10 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b6aa46-657b-2676-e063-6294a90abadd 2025-05-09 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Scottsdale Skin Boutique and Dermatology Pllc 34a5a99f-9e22-52ab-e063-6294a90a9323 2025-05-08 Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b7eeeb-09ae-ffe6-e063-6294a90aba90 2025-05-07 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation fe19a057-a3c6-4c53-92f9-a4a960cd5b08 2025-05-07 Warnings Exact identifier application number: M020 Winter Survival Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Duke Cannon Supply Co. 2487ab56-7856-66b0-e063-6394a90a9d87 2025-05-07 Warnings Exact identifier application number: M020 OS-01 Lip SPF BS SPF15 ZINC OXIDE Allure Labs 3490ed60-60b9-dfcd-e063-6394a90ab17a 2025-05-07 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Nude Beige ZINC OXIDE Koco Life LLC 3491084b-348a-f2bf-e063-6394a90abd25 2025-05-07 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Watermelon ZINC OXIDE Koco Life LLC 3491fb2a-d55f-1736-e063-6294a90a594a 2025-05-07 Warnings Exact identifier application number: M020 Abib Heartleaf mild sunscreen Relief tube ZINC OXIDE FOURCOMPANY CO., LTD. 34965587-c9b7-4066-e063-6394a90ab424 2025-05-07 Warnings Exact identifier application number: M020 CLARINS - MULTI-INTENSIVE JOUR SUPER RESTORATIVE DAY BROAD SPECTRUM - SPF 15 - SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Laboratoires Clarins 157cb8ca-1a36-41fb-be9e-b157b146dc4d 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 50 Sport AVOBENZONE, HUMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions e25e4f76-8311-491b-e053-2a95a90a4fc8 2025-05-06 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