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 269 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Banana Boat ZINC OXIDE Edgewell Personal Care Brands LLC 1ce728be-966e-b662-e063-6394a90a0ba8 2024-10-30 Warnings Exact identifier application number: M020 RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE COSMAX USA, INC. 2596a17e-4042-3544-e063-6294a90aa4c9 2024-10-29 Warnings Exact identifier application number: M020 Sunblocz ZINC OXIDE Olen Skin Care Corporation 36fec1f1-5e8b-5764-e054-00144ff8d46c 2024-10-29 Warnings Exact identifier application number: M020 Sunblocz Baby and Kids ZINC OXIDE Olen Skin Care Corporation 35cbb9d5-639c-207a-e054-00144ff88e88 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes) AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. fd7d40fe-178a-e1b1-e053-6294a90a29a1 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE ZO Skin Health, Inc. 9a4f5be1-da04-48b9-897a-57f4a3d9d1ec 2024-10-29 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Non-Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD e4a06973-21bb-4eda-9b74-fc23bee141ab 2024-10-29 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 2024-10-29 Warnings Exact identifier application number: M020 ZO Skin Health Broad-Spectrum Sunscreen SPF 50 TITANIUM DIOXIDE, ZINC OXIDE ZO Skin Health, Inc. d817f80b-a998-b67e-e053-2995a90a1971 2024-10-29 Warnings Exact identifier application number: M020 SPF 15 Coconut Lip Balm ZINC OXIDE Naples Soap Company, Inc. 25a7510f-5ef3-9920-e063-6394a90a2079 2024-10-29 Warnings Exact identifier application number: M020 Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection HOMOSALATE, OCTOCRYLENE, AVOBENZONE Bel Star S.A. (Colombia) a7d69691-cecc-798e-e053-2a95a90a995f 2024-10-28 Warnings Exact identifier application number: M020 LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F OCTINOXATE, ZINC OXIDE Bel Star S.A. eea17271-e8c8-ab21-e053-2995a90a2fcc 2024-10-28 Warnings Exact identifier application number: M020 LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BEL STAR SA fd90ffc6-a1e1-e02e-e053-6294a90a4e7c 2024-10-28 Warnings Exact identifier application number: M020 LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N OCTINOXATE, ZINC OXIDE BEL STAR S.A. 0b782198-58e7-5343-e063-6294a90a3713 2024-10-28 Warnings Exact identifier application number: M020 FHF Elevated Shade 100% Mineral Sunscreen SUNSCREEN Owen Biosciences Inc dabd3b95-01d3-014c-e053-2a95a90a0fec 2024-10-28 Warnings Exact identifier application number: M020 RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100 AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BAY BELLE LABS 259653e7-dfe0-44a2-e063-6294a90a416d 2024-10-28 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8a21acbe-2f3d-cf78-e053-2a95a90a77f6 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 7961ff9f-75db-4977-e053-2a91aa0ae628 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8a1c9a3c-394e-9122-e053-2995a90acb23 2024-10-27 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 8b889b75-07ac-4276-e053-2a95a90a69c6 2024-10-27 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