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 93 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15 OCTINOXATE AND ZINC OXIDE The Procter & Gamble Manufacturing Company 60183a47-fd02-052b-e053-2991aa0a1b5c 2025-12-31 Warnings Exact identifier application number: M020 Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar ZINC OXIDE The Procter & Gamble Manufacturing Company 026dcaee-d33c-b874-e063-6394a90ad2e7 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4745ab56-abaa-42de-e063-6394a90a6310 2025-12-31 Warnings Exact identifier application number: M020 Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 22f645cf-5182-9e3f-e063-6394a90adc84 2025-12-31 Warnings Exact identifier application number: M020 Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze ZINC OXIDE The Procter & Gamble Manufacturing Company 232032b7-803f-40ec-e063-6394a90a4b38 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 100 AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% Beiersdorf Inc e1a9a831-a0b9-17ba-e053-2a95a90a3fa7 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4745ebec-acb0-77c4-e063-6394a90aee07 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Baby Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 08134b95-1879-27e5-e063-6294a90a29af 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Oil Free SPF 50 Sunscreen AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8% Beiersdorf Inc ded1f158-36d1-153f-e053-2995a90ace30 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Kids Suncreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 08147940-0e8b-c894-e063-6394a90af8ac 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 70 AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% Beiersdorf Inc e468d703-fa6c-095a-e053-2a95a90a5194 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Waterbabies Pure and Simple Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 0806bdb9-961f-3146-e063-6294a90a4625 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPL 15 AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% Beiersdorf Inc df4b522e-93d4-1284-e053-2a95a90a1cd9 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Baby Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 088b7152-d3d1-9e74-e063-6394a90a4152 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 50 (TO DELIVER) AVOBENZONE 3%, HOMOSALATE 10%,OCTISALATE 5%, OCTOCRYLENE 5% Beiersdorf Inc 0a5a40ff-a014-3995-e063-6394a90a11e6 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47461ad3-a11e-2a11-e063-6294a90a0f8f 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Oil Free Sunscreen SPF 30 AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6% Beiersdorf Inc e451ecfb-cf17-c622-e053-2a95a90a4d4b 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 081484f8-58f5-f2a4-e063-6394a90a3379 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Kids Sunscreen SPF 50 ZINC OXIDE (24.08%) Beiersdorf Inc 09a97e3f-f6dc-eaa7-e063-6294a90ad274 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Kids Roll-On Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc f3e1ea21-4a07-3e18-e053-2995a90a0fe7 2025-12-31 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