SHISEIDO UV PROTECTIVE COMPACT (REFILL)
- Product NDC
- 58411-121
- 11-digit product format
- 584110121
- Labeler code
- 58411
- Product ID
- 58411-121_4ba6bd60-913b-4748-e063-6394a90aed10
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- SHISEIDO AMERICAS CORPORATION
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-02-01
- Substance
- OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
- Active strength
- 888; 600; 1416 mg/12g; mg/12g; mg/12g
- 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.
| 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 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 | 58411-121-30 | 0efc9e666f02… | f202fb6c5f17… |
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
- SHISEIDO UV PROTECTIVE COMPACT (REFILL)
- Brand name suffix
- FAIR IVORY
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 888 mg/12g |
| OCTOCRYLENE | 600 mg/12g |
| TITANIUM DIOXIDE | 1416 mg/12g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5A68WGF6WM | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c05cef12-a6a7-4682-9357-6d77f4ca3267 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58411-121-30 | SHISEIDO UV PROTECTIVE COMPACT (REFILL)FAIR IVORY | 12 g in 1 TRAY | POWDER | 12 | 8 | |
| 58411-121-30 | SHISEIDO UV PROTECTIVE COMPACT (REFILL)FAIR IVORY | 1 in 1 CARTON | POWDER | 1 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58411-121 | SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY (OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE) POWDER [SHISEIDO AMERICAS CORPORATION] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241225_c05cef12-a6a7-4682-9357-6d77f4ca3267.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 |
|---|---|---|---|---|---|---|
| Hydrating Mineral Zinc Oxide SPF 40 | ZINC OXIDE | Spalina LLC. | 35aa74c5-1bb3-9814-e063-6294a90a6999 | 2025-12-15 | M020 | |
| Mineral Tinted SPF40 with ceramides | ZINC OXIDE | Spalina LLC. | 35ac3bd1-a4c1-5078-e063-6394a90afdc8 | 2025-12-15 | M020 | |
| Suns Out Funs Out | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Koco Life LLC | 46040acf-512e-c867-e063-6294a90ac220 | 2025-12-15 | Warnings | M020 |
| Advanced Formula Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | CR KEEFE ENTERPRISES, INC. | 3981c878-826d-f685-e063-6294a90acb24 | 2025-12-15 | M020 | |
| Advanced Formula Tinted | TITANIUM DIOXIDE, ZINC OXIDE | CR KEEFE ENTERPRISES, INC. | 3984c4b7-94ee-2a8e-e063-6294a90ac24f | 2025-12-15 | M020 | |
| Ultra Tinted Protection | TITANIUM DIOXIDE, ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bc833d-f231-5f52-e063-6394a90a37a6 | 2025-12-15 | M020 | |
| Ultra Protection Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bc4586-5e62-c9e7-e063-6294a90a276b | 2025-12-15 | M020 | |
| 20Percent Zinc Total Protection | ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bcaee1-001b-82da-e063-6394a90a4a0f | 2025-12-15 | M020 | |
| Advanced Formula Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | CR KEEFE ENTERPRISES, INC. | 39821730-f6d1-c01a-e063-6394a90a026b | 2025-12-15 | M020 | |
| Advanced Formula Tinted | TITANIUM DIOXIDE, ZINC OXIDE | CR KEEFE ENTERPRISES, INC. | 3984920a-feb9-169c-e063-6394a90a9568 | 2025-12-15 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC | 35bdf417-45ba-f81a-e063-6394a90a7471 | 2025-12-15 | M020 | |
| Protection E And C Lightly Tinted | ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bce44e-d9f1-9279-e063-6394a90a6453 | 2025-12-15 | M020 | |
| Mineral Lip Protection | TITANIUM DIOXIDE, ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bd148c-43c7-aa93-e063-6394a90abc8b | 2025-12-15 | M020 | |
| Glow Shield | ZINC OXIDE | Kristina Lerner | 35be8766-1352-8967-e063-6294a90a896a | 2025-12-15 | M020 | |
| Sheer Tinted Protection | TITANIUM DIOXIDE, ZINC OXIDE | CLEAR SKIN SOLUTIONS, LLC | 35bd62d8-ebe3-b3fd-e063-6394a90a827c | 2025-12-15 | M020 | |
| PURE Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA JOLLA WELLNESS & AESTHETICS | 386bb911-9dbb-30fb-e063-6394a90a5e4d | 2025-12-15 | M020 | |
| PURE Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA JOLLA WELLNESS & AESTHETICS | 386c0261-68f9-6f27-e063-6294a90a8209 | 2025-12-15 | M020 | |
| PURE Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | LA JOLLA WELLNESS & AESTHETICS | 386c320b-22c3-7d35-e063-6394a90a4e0b | 2025-12-15 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CLEARLY BEAUTIFUL SKIN AND ACNE CLINIC LLC | 35bdc7f4-4e47-ce35-e063-6294a90acf2d | 2025-12-15 | M020 | |
| Non Tinted Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | VIDA HEALTH & WELLNESS LLC | 3724cb53-0198-c604-e063-6294a90aa64b | 2025-12-15 | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58411-121-30 | 58411012130 | 1 TRAY in 1 CARTON (58411-121-30) / 12 g in 1 TRAY | 1 tray | 2014-02-01 | 0000-00-00 | No | No | Current |