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 223 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24aa19c8-86d9-c691-e063-6394a90a691e 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a98d3d-f830-9614-e063-6394a90aa7d1 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM CHAMPAGNE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfb871b-460f-271a-e053-6394a90acad2 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g ZINC OXIDE NAKED SUNDAYS PTY LTD 2f42d22a-983e-d304-e063-6294a90a3719 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM ROSE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfbd0dd-8961-5fd0-e053-6294a90a5de4 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19g AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8% NAKED SUNDAYS PTY LTD 2f47a6c9-dd0a-da94-e063-6294a90a9a45 2025-03-22 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Firming Protocol TITANIUM DIOXIDE AND ZINC OXIDE Obagi Cosmeceuticals LLC 67ba9f32-bbf4-4c14-9e97-08f1cb7d3996 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Brightening Protocol HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 2f75ebf7-d6b6-45c6-ad5b-61739d260ff7 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d37581-122c-ec92-e063-6294a90ab425 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d3ed8c-f424-8d95-e063-6394a90a0cbc 2025-03-21 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. c7142781-fa57-43e5-9436-cb29dd03a669 2025-03-21 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 00ec7d9c-8550-45ce-8d0a-ef2caf84f98d 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Clarifiying Protocol SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 08ba9ea8-73fd-472b-9cc4-67df167352ec 2025-03-21 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3e51da46-6a81-4b74-b16e-3fc298a4ba59 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 2d2c58e2-0d15-4383-adae-12fc17b8ea50 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 1907126c-fd95-86e8-e063-6394a90a23ca 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC 4504a10d-6130-4ec5-823a-ab970709e6d7 2025-03-20 Warnings Exact identifier application number: M020 Vertra Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Eai-jr 286, Inc 30caf1dd-142d-85d3-e063-6394a90a0c88 2025-03-20 Warnings Exact identifier application number: M020 Sun Shades Lip Balm Cranberry Tangerine AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. f39606be-19c8-58d1-e053-2a95a90a908f 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC aa937596-2378-469f-a0e1-9700044e83b3 2025-03-20 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