SHISEIDO UV PROTECTIVE COMPACT (REFILL)
- Product NDC
- 58411-129
- 11-digit product format
- 584110129
- Labeler code
- 58411
- Product ID
- 58411-129_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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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 | 58411-129-30 | 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
- DARK 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 |
|---|---|
| 15FIX9V2JP | Internal UNII lookup |
| 5A68WGF6WM | Internal UNII lookup |
| 4Y5P7MUD51 | 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 |
|---|---|---|---|---|---|---|
| 58411-129-30 | SHISEIDO UV PROTECTIVE COMPACT (REFILL)DARK IVORY | 12 g in 1 TRAY | POWDER | 12 | 8 | |
| 58411-129-30 | SHISEIDO UV PROTECTIVE COMPACT (REFILL)DARK IVORY | 1 in 1 CARTON | POWDER | 1 | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58411-129 | 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 |
|---|---|---|---|---|---|---|
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d474fea9-65a7-672b-e053-2a95a90ab989 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 40 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | d4d9ad73-6394-2391-e053-2a95a90a2df6 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 100 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% | Beiersdorf Inc | df498e82-e1c9-51eb-e053-2a95a90a49b6 | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | d3984138-763b-1002-e053-2995a90acefc | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | d8b0d5ad-a82c-5304-e053-2a95a90afa63 | 2025-12-31 | Warnings | M020 |
| Coppertone Pure and Simple Sunscreen SPF 50 | ZINC OXIDE 24.08% | Beiersdorf Inc | d8d80a15-8282-a18e-e053-2a95a90a2c6c | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d915cb28-2813-5a38-e053-2a95a90a45c6 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 15 | AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d46052d3-6f45-5f4d-e053-2995a90a8760 | 2025-12-31 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | cc5dafd4-dfd4-d310-e053-2995a90a82a8 | 2025-12-31 | Warnings | M020 |
| Coppertone EveryTone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | 04c58384-fd82-f6d0-e063-6294a90a3ff1 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdort Inc | cc46b3a3-48f5-4593-e053-2995a90a8782 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sport SPF 60 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23fb7304-789d-1f94-e063-6394a90a7e62 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | cbf9a785-f218-76fb-e053-2995a90a8e03 | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Hydragel Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | b60c2a38-ef92-0dff-e053-2995a90a47c4 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | (TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | 0a5a5370-ec6f-42a7-e063-6394a90ac37c | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d53e1253-f6a4-4f3d-e053-2a95a90a79ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Face SPF 60 Plus Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 04b36eb1-bffc-c31e-e063-6294a90a8eb3 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d47460a1-4768-ee44-e053-2a95a90adecf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 50 | ZINC OXIDE 20% | Beiersdorf Inc | d46359e7-b585-c43a-e053-2995a90a0863 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d473e7ed-4a9f-76fe-e053-2995a90ab37d | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58411-129-30 | 58411012930 | 1 TRAY in 1 CARTON (58411-129-30) / 12 g in 1 TRAY | 1 tray | 2014-02-01 | 0000-00-00 | No | No | Current |