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 224 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Obagi Medical Way to Glow Kit HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC f6f6e219-4ef6-be3b-e053-6294a90a660d 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC e8d19915-8996-42df-a47b-2ce00d2bbe68 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE SHISEIDO AMERICAS CORPORATION 21bde283-a554-45c8-8733-2a8adeff41b1 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE SHISEIDO AMERICAS CORPORATION 7a98171f-bf21-40d4-bc78-883aa0b0c438 2025-03-20 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 5e2d7c94-d70a-47e4-9a4b-5953fe38ede2 2025-03-19 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 50206f9e-2dd5-494f-9eed-f7d7ea6efda9 2025-03-18 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE The Creme Shop 30a4280b-4a9f-4c18-e063-6394a90a85e6 2025-03-18 Warnings Exact identifier application number: M020 Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45 ZINC OXIDE Eai-jr 286, Inc 30a5ec14-63d7-e678-e063-6294a90abb57 2025-03-18 Warnings Exact identifier application number: M020 EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Extra Shade, LLC d197dfe3-c754-4a3d-9edd-335f3fce105c 2025-03-18 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c88e44da-0b0e-4744-8b4b-4d9d418f29d7 2025-03-18 Warnings Exact identifier application number: M020 MDP UV BIO SUNSCREEN ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE SKINIDEA CO., LTD 3087771e-2ab8-2198-e063-6294a90a37d4 2025-03-17 Warnings Exact identifier application number: M020 belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG H&H CO., LTD. 2b38da59-b83e-4285-e063-6294a90ac6a7 2025-03-17 Warnings Exact identifier application number: M020 SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 263ef8e8-e0c4-42e6-bb26-7581a437b35a 2025-03-14 Warnings Exact identifier application number: M020 Impact Melanoma SPF 30 ZINC OXIDE RENU LABORATORIES, LLC f953302e-f712-129a-e053-6294a90ab9a8 2025-03-13 Warnings Exact identifier application number: M020 Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38 TITANIUM DIOXIDE Eai-jr 286, Inc 303d5d5a-4c7a-1e23-e063-6294a90a0e58 2025-03-13 Warnings Exact identifier application number: M020 belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50 ZINC OXIDE LG H&H CO., LTD. 2b4c363b-f767-7901-e063-6394a90adba5 2025-03-13 Warnings Exact identifier application number: M020 Zinc Oxide MINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREEN Vege Labs LLC 303e84e1-3bea-ea6f-e063-6294a90aeaa7 2025-03-13 Warnings Exact identifier application number: M020 MURASAKI BEAUTY Silicence Scar Gel SPF 30 ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE Haikou Pucao Trading Co.,Ltd 303f7dd6-aef2-30ce-e063-6394a90ac00f 2025-03-13 Warnings Exact identifier application number: M020 SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110 OCTINOXATE SHISEIDO AMERICAS CORPORATION 393ce1fa-f188-45d0-a23e-2818de974995 2025-03-13 Warnings Exact identifier application number: M020 SHISEIDO FUTURE solution LX TOTAL PROTECTIVE S AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 1a304bf0-dcda-4887-9738-54ce35ca503b 2025-03-13 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