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 205 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Vine Vera Resveratrol Cabernet Replenishing Moisture OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. c48a7346-3971-4946-b527-a5549a98e246 2025-07-07 Warnings Exact identifier application number: M020 Lavelier Divine Day Defense Broad Spectrum SPF 30 OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 1f33a93f-ae3f-4024-9d23-26b01eed1764 2025-07-03 Warnings Exact identifier application number: M020 HIGHHEAT Sunscreen SPF 50 Performance For Athletes AVOBENZONE, OCTISALATE, OCTOCRYLENE DUGOUT ESSENTIALS LLC 3b7cddb5-00d2-4998-8eec-5e5a7c5a6097 2025-07-03 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CAPE COD SKIN CARE CO. INC. 39093b2d-3fbb-8378-e063-6294a90ac6d8 2025-07-03 Exact identifier application number: M020 Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 09ccb37b-78ee-b510-e063-6294a90a48d5 2025-07-01 Warnings Exact identifier application number: M020 First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Port Jervis Laboratories, Inc. 4b442fdf-a9cf-7e5a-e063-6394a90a9e1e 2025-07-01 Warnings Exact identifier application number: M020 Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE Sincerely Yours Inc. 4c9dfa22-70f7-83f6-e063-6394a90aa8c5 2025-07-01 Warnings Exact identifier application number: M020 Nova Bright Skin SPF 30 OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE Innovation Brands Inc. 1c201147-7a54-41b5-bdf0-394e3d7efc0c 2025-07-01 Warnings Exact identifier application number: M020 Introstem Vitiscell Facial Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 65c28ed6-649d-41d9-b214-aab6ccb02dd5 2025-07-01 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 38d049b4-557f-724a-e063-6394a90a19b3 2025-06-30 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 2f74965f-3c84-0590-e063-6294a90af267 2025-06-30 Warnings Exact identifier application number: M020 Bath and Body Works SPF Tahiti Isle AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Bath & Body Works, Inc. 38d0d165-e981-284a-e063-6294a90acace 2025-06-30 Warnings Exact identifier application number: M020 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERAINE DOUBLE REPAIR MATTE MOISTURIZER UV BROAD SPECTRUM SPF 30 FOR OILY, COMBINATION SKIN AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE LOreal USA Products Inc a3dc6195-3011-4e7f-b1b0-0c815b11ba8d 2025-06-30 Warnings Exact identifier application number: M020 Youth to the People Youthscreen Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE AND OCTISALATE LOreal USA Products Inc 5712df74-5201-474b-bbfd-703f3117bd9c 2025-06-30 Warnings Exact identifier application number: M020 BINDA Vitamin C and hyaluronic acid Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38bff6d0-5690-3ee5-e063-6294a90a9faa 2025-06-29 Warnings Exact identifier application number: M020 Vertra S Dorian Kona Gold Signature Face Stick SPF 38 TITANIUM DIOXIDE Toshiki Pigment Co., ltd. b7162a2f-07f1-6188-e053-2995a90a8a9c 2025-06-27 Warnings Exact identifier application number: M020 Orchidee Double Defense Skin Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 74b3c33f-5db5-460d-97be-fa495b625249 2025-06-27 Warnings Exact identifier application number: M020 GHOSTED ZINC OXIDE Spooge a5b611c3-d4d3-461e-84d8-d04a29c74902 2025-06-26 Warnings Exact identifier application number: M020 Dew Me ZINC OXIDE Spooge 0c4b429b-7dd5-4929-95af-d02b6770f121 2025-06-26 Warnings Exact identifier application number: M020 Zinc FIVE-0 baby and kids mineral sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38744f77-4845-eac4-e063-6294a90af648 2025-06-26 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