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 343 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 97e7ece8-a705-4988-ba52-6d3f11573521 2021-12-01 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 6a44f926-11b4-4bc4-8d5d-721a89c4f0cc 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS b58af664-b0fd-4585-8417-7c20954d7aff 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 7bbd1334-fae8-4274-b927-a099af764345 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 970571f9-3d6b-46ae-a668-745de1911fa2 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 542e1b2e-f63c-466b-b5ac-6c147a0e9dec 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 21b65c12-6f67-4053-9508-6b2709cc1fb8 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 8ea4c470-ebd5-448e-b72a-ccd1113de0ab 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS fd9689a4-21d1-49f0-bf59-b8e1da72cd16 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS c23b6a87-8cf9-4be3-8306-2285e7e926c1 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS a93cb6c6-d7c2-43cc-a2e8-961f896a977e 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 32d99955-1593-426b-958e-5dcf689192a3 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 762deb57-754b-46a9-9907-de05e11da178 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3b5366e4-180a-4b98-9524-63601ae9d270 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e 2021-11-04 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3e67abb5-84a4-4a78-9ea3-9fd57cbeb482 2021-11-04 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 477d79c1-f169-4d0e-a95d-f5e832855f0d 2021-11-04 Warnings Exact identifier application number: M020 Anhydrous SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Owen Biosciences, Inc. 1510cae2-9c8f-45ba-b088-67747af3d30c 2021-07-15 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3f0480e4-b2c3-962c-e063-6294a90a4f23 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS aa708db4-ad90-49b7-a250-5698e4c7d3d6 2021-07-13 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