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 214 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mango Bay SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions LLC. e260b901-5918-48df-e053-2a95a90a68c3 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions LLC. e25cf8e4-93cd-f5f6-e053-2995a90a4545 2025-05-06 Warnings Exact identifier application number: M020 Mango Bay SPF 30 Gallon AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Inspec Solutions LLC. e260c1bc-8b79-abc7-e053-2a95a90ae4d2 2025-05-06 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Pink Strawberry ZINC OXIDE Koco Life LLC 347e665f-cb59-ab04-e063-6394a90ad0a6 2025-05-06 Warnings Exact identifier application number: M020 Saucd Toasted Golden Tanning SPF 15 Caramel AVOBENZONE, OCTISALATE, HOMOSALATE SAUCD GENERAL TRADING COMPANY e10d41cd-e03e-401c-9024-263350b3ec2a 2025-05-05 Warnings Exact identifier application number: M020 Visor Clear Body Mist Hydrating Sunscreen SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE VISOR SKINCARE LLC b2d7639c-cbfb-4127-8ee4-7355e0d021e1 2025-05-05 Warnings Exact identifier application number: M020 Jacket Ultimate Performance Sunscreen SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BALSHI MD DERMACEUTICALS d4d82c41-01da-40af-a22c-d4d57af7a2f2 2025-05-05 Warnings Exact identifier application number: M020 All Good Mineral Sport Sunscreen Butter Stick SPF 50 ZINC OXIDE Elemental Herbs, Inc. 114c6ac8-b133-cd16-e063-6294a90ac4f9 2025-05-05 Warnings Exact identifier application number: M020 All Good kids mineral sunscreen butter stick SPF 50 ZINC OXIDE Elemental Herbs, Inc. feb94fd7-6727-6fb1-e053-6394a90a2af1 2025-05-05 Warnings Exact identifier application number: M020 Vivier Sheer SPF 30 Mineral Tinted TITANIUM DIOXIDE, ZINC OXIDE Vivier Pharma, Inc. e12e3bcb-4c3d-41be-8e2b-12a817c8b367 2025-05-05 Warnings Exact identifier application number: M020 EVERY DAY MINERAL SUN SCREEN SPF 45 ZINC OXIDE Stream2Sea, LLC 7ec4954f-7d60-405b-8bff-cb602fc44a4e 2025-05-04 Warnings Exact identifier application number: M020 ABIB QUICK AND AIRY SUNSTICK DUO SET HOMOSALATE, OCTOCRYLENE,OCTISALATE,AVOBENZONE FOURCOMPANY CO., LTD. 34292261-4d05-e07d-e063-6294a90a4741 2025-05-02 Warnings Exact identifier application number: M020 LION POSE UNGHOSTED TINTED MINERAL SPF 42 UVA UVB SUNSCREEN ZINC OXIDE Lion Pose Inc. 341b90b4-82ae-e8c6-e063-6394a90aeefd 2025-05-01 Warnings Exact identifier application number: M020 LAPCOS DAILY SUNSCREEN SPF 50 SUNSCREEN LAP USA, INC. 337c3528-5739-6b4a-e063-6294a90a3cb4 2025-05-01 Warnings Exact identifier application number: M020 Hiya Kids SPF 40 Mineral Sunscren ZINC OXIDE Hiya Health Products LLC 33119ec6-2cd8-8978-e063-6394a90afd97 2025-05-01 Warnings Exact identifier application number: M020 EltaMD UV AOX Elements ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc d01756c0-1f82-4e08-b956-8000ecaddfd1 2025-05-01 Warnings Exact identifier application number: M020 Broad Spectrum SPF45 ZINC OXIDE, OCTINOXATE Drmtlgy, LLC ce93b371-26ab-4493-98e0-98234c3a9ba6 2025-05-01 Warnings Exact identifier application number: M020 Winter Rescue Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE DUKE CANNON SUPPLY CO. 24356548-348d-2cd2-e063-6294a90ab352 2025-04-29 Warnings Exact identifier application number: M020 Prequel Lip Visor SPF 30 CLEAR LIP 30 CLEAR The Center Brands, LLC 33d5d1d4-c516-238c-e063-6294a90ac11c 2025-04-28 Warnings Exact identifier application number: M020 LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BEL STAR SA 33db89ac-2653-78f5-e063-6394a90af03d 2025-04-28 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