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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 36800-167 | D | Discontinued by firm | 2026-11-03 | ||
| excluded package | package | 36800-167 | 36800-167-08 | D | Discontinued by firm | 2026-11-03 |
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.
| 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 |
|---|---|
| OCTOCRYLENE | 70 mg/mL |
| OCTISALATE | 50 mg/mL |
| HOMOSALATE | 100 mg/mL |
| AVOBENZONE | 30 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5A68WGF6WM | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| G63QQF2NOX | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c6268778-8dcc-24b6-e053-2995a90acf03 | Available on FDA.report |
DailyMed Package Descriptions#
| 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE | MAKEUP ART COSMETICS | c26ef380-1309-4a41-862f-eb319d38673d | 2024-12-25 | Warnings | M020 |
| STUDIO FIX FLUID SPF 15 BROAD SPECTRUM | OCTINOXATE AND TITANIUM DIOXIDE | MAKEUP ART COSMETICS | ff48435d-245a-4037-9afb-caee83c4c415 | 2024-12-25 | Warnings | M020 |
| ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40 | OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE | ORIGINS NATURAL RESOURCES INC. | 0fe63edf-7a49-4b33-88f1-f480f889d194 | 2024-12-25 | Warnings | M020 |
| DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30 | HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE | ORIGINS NATURAL RESOURCES INC. | 8e8c495e-d439-4735-a7cc-b44081b75b27 | 2024-12-25 | Warnings | M020 |
| VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15 | AVOBENZONE, OCTISALATE, AND OCTOCRYLENE | ORIGINS NATURAL RESOURCES INC. | 0fac5204-df18-4774-bb53-115513cb7ff0 | 2024-12-25 | Warnings | M020 |
| LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20 | TITANIUM DIOXIDE | MAX HUBER RESEARCH LAB INC | 66e48ce0-9a5b-4250-b07b-1622b3814c3e | 2024-12-25 | Warnings | M020 |
| ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19 | OCTINOXATE AND TITANIUM DIOXIDE | ESTEE LAUDER INC | 2f93580c-c8e9-4822-91bf-a749cf4deb4e | 2024-12-25 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06b14a17-cab9-1b3e-e063-6394a90afe5d | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 06ab109e-abcf-0861-e063-6394a90a9375 | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0d3379ba-465d-a889-e063-6394a90aaf23 | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0d339273-6d82-0979-e063-6394a90a3de7 | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0cc97b34-e9e6-ef6a-e063-6394a90aee89 | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0cc9760b-b88b-f291-e063-6294a90a242f | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0d338ec2-dca0-e032-e063-6394a90a69aa | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0752d79d-5d82-0367-e063-6394a90a4f1c | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0d33888d-20b3-f912-e063-6394a90a25dc | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0d3379ba-465c-a889-e063-6394a90aaf23 | 2024-12-25 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06b25290-33a0-bafd-e063-6394a90a7a94 | 2024-12-25 | Warnings | M020 |
| Leg Body Makeup | OCTISALATE, OCTOCRYLENE | COSMAX USA, CORPORATION | 0751b356-607f-f3cb-e063-6294a90a4092 | 2024-12-25 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06b14a17-cace-1b3e-e063-6394a90afe5d | 2024-12-25 | Warnings | M020 |
Packages#
| 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 |