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 216 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chardonnay Lip Oil AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Vacation Inc 1318a429-d382-f5b8-e063-6394a90a3bd4 2025-04-18 Warnings Exact identifier application number: M020 Shimmer Oil AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE Vacation Inc. 131c63ba-57fc-9ce8-e063-6294a90acd92 2025-04-18 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Edgewell Personal Care Brands LLC 055431a6-e9e0-99b4-e063-6394a90acb11 2025-04-17 Warnings Exact identifier application number: M020 SILKEN pore perfecting sunscreen broad spectrum SPF 35 OCTISALATE, ZINC OXIDE TATCHA INC. 251566a1-0e21-4030-9d4e-52c4a8bd3330 2025-04-16 Warnings Exact identifier application number: M020 Dermatone SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Dermatone Labs LLC 32e5bddf-a0b5-c511-e063-6294a90aaf66 2025-04-16 Warnings Exact identifier application number: M020 Sunscreen Lip Balm SPF 30 Cool Mint AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9% USRX 3271ab14-3bf5-a24f-e063-6294a90a59bc 2025-04-16 Warnings Exact identifier application number: M020 goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE CLIO COSMETICS Co., Ltd. 77a0d190-f558-474b-89d2-c79b37c50c0d 2025-04-16 Warnings Exact identifier application number: M020 Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILL ZINC OXIDE SPF Ventures, LLC 32ccb93a-50cf-f436-e063-6294a90a2492 2025-04-15 Warnings Exact identifier application number: M020 DECORTE SUN SHELTER MULTI PROTECTION Sunscreen SPF 50 Broad Spectrum AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE KOS America, Inc. 2b41c17d-1394-0c2f-e063-6394a90a0c49 2025-04-15 Warnings Exact identifier application number: M020 Urban Antioxidant Sunscreen SPF 40 HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAM Dr. Loretta, LLC 930150a3-08bb-17fd-e053-2995a90a786b 2025-04-15 Warnings Exact identifier application number: M020 Cicapair Soothing Color Correcting Treatment Cica Complex Broad Spectrum SPF 30 TITANIUM DIOXIDE AND ZINC OXIDE Have & Be Co., Ltd. 32c1aba6-5e29-aba9-e063-6394a90a8e56 2025-04-14 Warnings Exact identifier application number: M020 REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE CLINIQUE LABORATORIES LLC 07701e11-8a7e-44c5-b46e-5b48264eacad 2025-04-14 Warnings Exact identifier application number: M020 Dr.Ceuracle HYDRA BARRIER SUNSCREEN ZINC OXIDE Leegeehaam Cosmetics 22c05215-4983-b32e-e063-6394a90a9f67 2025-04-13 Warnings Exact identifier application number: M020 No7 Protect and Perfect Intense Advanced Day Cream SPF 30 AVOBENZONE,OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 3285e28d-5716-b576-e063-6294a90a8905 2025-04-11 Warnings Exact identifier application number: M020 No7 Protect and Perfect Intense Advanced Fragrance Free Day Cream SPF 30 AVOBENZONE,OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 32876315-f81f-fdd2-e063-6394a90ad5f7 2025-04-11 Warnings Exact identifier application number: M020 No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 3287ae2e-759e-31c5-e063-6394a90a892f 2025-04-11 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Fragrance Free Day Cream SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE BCM Cosmetique SAS 32b5a19e-86d4-5ee1-e063-6394a90a12e2 2025-04-11 Warnings Exact identifier application number: M020 LERINN ZINCPURE SUNMILK SPF 50 ZINC OXIDE Serrina Lin Skincare Inc 32717b49-729c-a229-e063-6394a90a18fb 2025-04-10 Warnings Exact identifier application number: M020 Smoothing Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE DANIEL BEHROOZAN MD A MEDICAL CORPORATION 327246c2-9d7a-2d34-e063-6294a90a5fb7 2025-04-10 Exact identifier application number: M020 Clarity Rx Physical Skin Defense SPF 50 ZINC OXIDE AND TITANIUM DIOXIDE Topiderm, Inc. b5111012-97b9-4908-95a0-d09595f9c4d9 2025-04-10 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