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 332 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PRIDEFUL SPF 15 LIP BALM-passion fruit HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC d6b6389b-c8bd-4aca-8ccf-455dbc22070d 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-coconut HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC a6af5cdc-999d-45ba-a7a6-5e7330f8b9c0 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-melon HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC e201fec6-eb69-40fb-8459-02d64e34a3b7 2023-10-26 Warnings Exact identifier application number: M020 PRIDEFUL SPF 15 LIP BALM-orange mango HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE PRIDEFUL LLC c50c9f00-6a0f-4307-b35d-7fc5fa3b7edf 2023-10-26 Warnings Exact identifier application number: M020 BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC e5fcb1fd-ad61-1ea5-e053-2a95a90a2472 2023-10-26 Warnings Exact identifier application number: M020 Grape Soda SPF 15 Broad Spectrum Lip Balm GRAPE SODA SPF 15 BROAD SPECTRUM LIP BALM Raining Rose, Inc a09a0b5f-93e4-d18a-e053-2a95a90a65f7 2023-10-26 Warnings Exact identifier application number: M020 Beeswax SPF 30 Broad Spectrum Lip Balm BEESWAX SPF 30 BROAD SPECTRUM LIP BALM Raining Rose, Inc a962bfca-03a3-8dde-e053-2a95a90abbb9 2023-10-26 Warnings Exact identifier application number: M020 Cream ZINC OXIDE Oxygen Development LLC 08a1e862-b55a-fb84-e063-6294a90a016a 2023-10-26 Warnings Exact identifier application number: M020 SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE THE KROGER COMPANY a52872bf-cd0f-06da-e053-2995a90af28d 2023-10-26 Warnings Exact identifier application number: M020 Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30 ZINC OXIDE Babo Botanicals, Inc. 08a36887-3997-8fff-e063-6394a90ae9d5 2023-10-26 Warnings Exact identifier application number: M020 PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 TITANIUM DIOXIDE AND ZINC OXIDE ESTEE LAUDER INC e87c4a76-5f21-4989-a1e0-0b7c6902f201 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Unflavored Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALM Raining Rose efe20472-aa84-1cb4-e053-2a95a90abfd8 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Mint Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALM Raining Rose efe1113b-6101-0c15-e053-2a95a90a02a7 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALM Raining Rose efe176f7-9c11-106e-e053-2a95a90a9c88 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Citrus Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALM Raining Rose efdfc182-3ac0-1a3d-e053-2a95a90a894e 2023-10-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 15 Sunscreen Iced Pear Lip Balm BROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALM Raining Rose efe01abd-0ee2-6bd6-e053-2a95a90a123d 2023-10-26 Warnings Exact identifier application number: M020 Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40 TITANIUM DIOXIDE, ZINC OXIDE NATURA BISSE INTERNATIONAL SA bf8b71c7-257b-0eb6-e053-2a95a90a3a4c 2023-10-26 Warnings Exact identifier application number: M020 Carmex Weather Guard Moisturizing Lip Balm SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Carma Laboratories, Inc. 843677f2-78fa-4f3d-9fe6-e45e35b728e3 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. baec9be7-5ae6-135c-e053-2995a90a2ed4 2023-10-25 Warnings Exact identifier application number: M020 Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. baea3596-6eb0-4d98-e053-2995a90a75cc 2023-10-25 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