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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct36800-167DDiscontinued by firm2026-11-06
excluded packagepackage36800-16736800-167-08DDiscontinued by firm2026-11-06

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage36800-167-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage36800-167-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage36800-167-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage36800-167-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage36800-167-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage36800-167-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage36800-167-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage36800-167-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage36800-167-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage36800-167-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage36800-167-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage36800-167-08557ba5c1ecfa…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
IngredientStrength
OCTOCRYLENE70 mg/mL
OCTISALATE50 mg/mL
HOMOSALATE100 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6268778-8dcc-24b6-e053-2995a90acf03Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-167-09Topcare Everyday Ultimate Sheer Sun Broad Spectrum SPF 5589 mL in 1 TUBELOTION892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-167TOPCARE EVERYDAY ULTIMATE SHEER SUN BROAD SPECTRUM SPF 55 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [TOPCO ASSOCIATES LLC]2Current NDC, Legacy NDC, 1 package rows20241017_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 337 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum SunscreenENSULIZOLE, OCTINOXATE, ZINC OXIDEAmway Corp6aaec5a4-701e-4870-896d-f68f62448c7a2023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum SunscreenTITANIUM DIOXIDEAmway Corpa83f1192-c6c7-4145-b5af-29202191db782023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Buff L1W1TITANIUM DIOXIDEAmway Corpcba2462d-71ec-4ecb-b05a-5208ff8e22ad2023-10-21WarningsExact identifier
application number: M020
ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 SunscreenOCTINOXATE, OXYBENZONEAmway Corp8cde14ae-b886-4bd2-b2bd-db604373984a2023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Brule L4W1TITANIUM DIOXIDEAmway Corp19d08a86-5a60-4633-8a3c-96bab9a17fcc2023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Chablis L1C1TITANIUM DIOXIDEAmway Corpd17b1d46-478e-4f48-8fde-ac639bcdc4922023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Chiffon L2C1TITANIUM DIOXIDEAmway Corp750ca57c-e8e9-4be0-84b1-7f55487f7bf62023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cream L1W2TITANIUM DIOXIDEAmway Corp192dac09-2887-4622-b3d4-c6a9c16b4f882023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Mink L6W1TITANIUM DIOXIDEAmway Corpaf6d38d5-69ab-4d7e-b534-b2c2bcf368472023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Ochre L2N1TITANIUM DIOXIDEAmway Corp7f545d32-b38c-4f6a-a413-7f29e1aa2bc32023-10-21WarningsExact identifier
application number: M020
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZERAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONECLINIQUE LABORATORIES LLC2e9463df-1c71-465f-9820-6cedefe07ad72023-10-20WarningsExact identifier
application number: M020
EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20AVOBENZONE, OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC2ccf568b-b8ff-414d-b15d-0cab6a57a8012023-10-20WarningsExact identifier
application number: M020
CL EB MATTE MAKEUP BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC082b297e-d1d9-16b2-e063-6294a90a2ffd2023-10-20WarningsExact identifier
application number: M020
Farmasi BB Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI062ffd88-2016-3c4d-e063-6394a90a5cf92023-10-20WarningsExact identifier
application number: M020
Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30ZINC OXIDEUSANA Health Sciences, Inc.c10c188c-66e0-18ec-e053-2a95a90a5a7d2023-10-19WarningsExact identifier
application number: M020
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATIONAVOBENZONE, HOMOSALATE, AND OCTISALATECLINIQUE LABORATORIES LLCb0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be02023-10-19WarningsExact identifier
application number: M020
CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25TITANIUM DIOXIDE, ZINC OXIDECLINIQUE LABORATORIES LLC884abba1-891d-4c3c-b203-38a5a8a577562023-10-19WarningsExact identifier
application number: M020
MARA Algae Zinc Sea Kale Sunscreen Serum SPF 30ZINC OXIDEMara Beauty LLCba986280-eea3-b49c-e053-2995a90a39572023-10-19WarningsExact identifier
application number: M020
Valmont Daily Veil. Moisturizing Face Fluid Mineral SunscreenZINC OXIDEInnovation Labs, Inc.87a4b9c0-c33d-4bde-b455-dc8c33d8bb9c2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA MINT LIP BALMRaining Roseefe25551-777c-5336-e053-2a95a90a5c232023-10-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-167-093680001670989 mL in 1 TUBE (36800-167-09) 89 ml2019-07-240000-00-00NoNoCurrent