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 326 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3W OCTISALATE, TITANIUM DIOXIDE Guerlain 15fe0429-720c-4975-953d-285aa7ee12ce 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4W OCTISALATE, TITANIUM DIOXIDE Guerlain 1a733548-75a4-41ec-8d8d-3e6e9aad52e0 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8N OCTISALATE, TITANIUM DIOXIDE Guerlain f43c867a-161f-47b7-b3d8-7f7e6c672804 2023-11-08 Warnings Exact identifier application number: M020 Aruba Sun SPF 70 Sunscreen AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% Derma Care Research Labs, LLC d96b4233-6d52-7621-e053-2a95a90a1b60 2023-11-08 Warnings Exact identifier application number: M020 PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0C OCTISALATE, TITANIUM DIOXIDE Guerlain 0d75be99-7607-4964-bb6e-3c731644ab4e 2023-11-08 Warnings Exact identifier application number: M020 Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE AHAVA Dead Sea Laboratories Ltd dee4bdb8-5c6f-42f6-b15c-d109cd2d3140 2023-11-08 Warnings Exact identifier application number: M020 Mineral Radiance Energizing Day BS SPF 15 AVOBENZONE, HOMOSALATE, AND OCTISALATE AHAVA Dead Sea Laboratories Ltd 4cb8b21c-7727-441a-9d61-c90d79ac45dc 2023-11-08 Warnings Exact identifier application number: M020 Jack Black Intense Therapy Lip Balm Passion Fruit AVOBENZONE, OCTINOXATE LIP BALM SUNSCREEN Jack Black, LLC f34beb68-e5dc-45c4-a6d1-e9a031016228 2023-11-08 Warnings Exact identifier application number: M020 Private Label SPF45 Water Resistant Paraben Free Sunscreen OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC f997f4fc-7da5-433c-9a53-2030b489b4f6 2023-11-07 Warnings Exact identifier application number: M020 Private Label Moisturizing Oil Free Paraben Free SPF43 SUNSCREEN Swiss-American CDMO, LLC 003e4221-f9d9-47c4-b10b-9876046b931a 2023-11-07 Warnings Exact identifier application number: M020 AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE AHAVA Dead Sea Laboratories Ltd 5a9ec221-a9ec-4473-8fb0-83f10ae775e2 2023-11-07 Warnings Exact identifier application number: M020 Private Label Super Light Oil-Free SPF45 2.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREEN Swiss-American CDMO, LLC 6a08448a-46bc-4330-ae2d-f716bb4edfa7 2023-11-07 Warnings Exact identifier application number: M020 GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30 OCTINOXATE, OCTISALATE, ZINC OXIDE TT Fitness, Inc 617ef3af-4203-4664-b714-1b5fab2e0ee6 2023-11-06 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Clear Moisture Mineral SPF-30 ZINC OXIDE The Seaweed Bath Co. c241261c-d887-4ac2-89ce-93dcc0fce267 2023-11-06 Warnings Exact identifier application number: M020 JESS BEAUTY Let It Sun Sunscreen SPF-50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE JESS BEAUTY PRODUCTS LLC 88628c11-dbc7-4404-9701-7944a685a13d 2023-11-06 Warnings Exact identifier application number: M020 SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50 ZINC OXIDE The Seaweed Bath Co. fdcfc7eb-da33-4461-a4f9-fe97ea6b873f 2023-11-06 Warnings Exact identifier application number: M020 SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42 TITANIUM DIOXIDE, ZINC OXIDE SANTO REMEDIO LLC 82d210bc-b7ca-4d74-be58-85f175a75058 2023-11-06 Warnings Exact identifier application number: M020 CALIFORNIA MANGO SPF-50 SUNSCREEN AVOBENZONE, OCTISALATE, OCTOCRYLENE CALMANGO, INC 183e523a-93ee-47ec-8bd4-5557af449ea5 2023-11-06 Warnings Exact identifier application number: M020 Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE NEWCO LLC fa3c73a3-0dfb-4673-822a-45d946dee260 2023-11-06 Warnings Exact identifier application number: M020 JESS BEAUTY Sun Drops Sunscreen Oil SPF-50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE JESS BEAUTY PRODUCTS LLC 4e05e9d6-5127-44ca-a331-3004b2ddb534 2023-11-06 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