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 |
|---|---|---|---|---|---|---|
| Ceile tint PROTECT tinted serum SPF 50 Ivory | CEILE TINT PROTECT TINTED SERUM SPF 50 IVORY | LE COSMETICS INC | 58547809-3480-1032-e063-6294a90a04c6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM DEEP | LE COSMETICS INC | 58549160-3594-9056-e063-6394a90abf7d | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Deep | CEILE TINT PROTECT TINTED SERUM SPF 50 DEEP | LE COSMETICS INC | 585498d4-b29c-9580-e063-6394a90adf1e | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Fair | CEILE TINT PROTECT TINTED SERUM SPF 50 FAIR | LE COSMETICS INC | 58545633-cb36-6611-e063-6394a90a1f07 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT | LE COSMETICS INC | 5853ae6b-0eaf-e614-e063-6394a90ae91a | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Light Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 LIGHT MEDIUM | LE COSMETICS INC | 585473c3-3ee9-7d84-e063-6394a90abd33 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM | LE COSMETICS INC | 58547b48-251a-10eb-e063-6294a90ac95c | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TAN | LE COSMETICS INC | 58547e38-ae84-82ee-e063-6394a90a27d6 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Tan | CEILE TINT PROTECT TINTED SERUM SPF 50 TAN | LE COSMETICS INC | 58548331-38cd-8668-e063-6394a90a3362 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEY | LE COSMETICS INC | 5854861a-376d-8825-e063-6394a90a8aab | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Honey | CEILE TINT PROTECT TINTED SERUM SPF 50 HONEY | LE COSMETICS INC | 585488c5-fac5-212f-e063-6294a90a00ff | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Medium Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICH | LE COSMETICS INC | 585488af-d14f-8d71-e063-6394a90ac4f0 | 2026-08-05 | Warnings | M020 |
| Ceile tint PROTECT tinted serum SPF 50 Rich | CEILE TINT PROTECT TINTED SERUM SPF 50 RICH | LE COSMETICS INC | 58548e6d-9c82-249c-e063-6294a90a11ad | 2026-08-05 | Warnings | M020 |
| 12 Days of Derm-Loved Skincare | OCTINOXATE, ZINC OXIDE, OATMEAL, BENZOYL PEROXIDE, AVOBENZONE, OCTISALATE, OCTOCRYLENE | Rodan & Fields | a13f0275-5add-4464-88d4-ff9823274325 | 2026-08-03 | Warnings | M020 |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | M020 |
| Manyo Air Light Moisturizing Sunscreen SPF 50 | ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Manyo Factory Corp. | 86761577-a32c-41a2-a2e3-b339b1493701 | 2026-08-03 | Warnings | M020 |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | M020 |
| AMBI SKINCARE Even and Clear Daily Facial Moisturizer SPF 30 | OCTISALATE, OCTOCRYLENE, AVOBENZONE | AMBI Enterprises LLC | 99bbe9a2-bb57-4a33-b339-1649d4b319c8 | 2026-07-31 | Warnings | M020 |
| AMBI Even and Clear Facial Moisturizer SPF-30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | AMBI Enterprises LLC | 4701c0ba-4ceb-4d66-9f99-515ce33b4648 | 2026-07-31 | Warnings | M020 |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | Warnings | 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 |