78 x 36 SPF 30 Active
- Product NDC
- 58466-109
- 11-digit product format
- 584660109
- Labeler code
- 58466
- Product ID
- 58466-109_1c2b73fd-1c52-4db3-982e-d937c04ceeac
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ZINC OXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Dermazone LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-10-01
- Substance
- ZINC OXIDE
- Active strength
- .2 g/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58466-109-03 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58466-109-03 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58466-109-03 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58466-109-03 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58466-109-03 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 58466-109-03 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 58466-109-03 | U | Excluded because listing certification expired | 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
- 78 x 36 SPF 30 Active
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | .2 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 96a8aacc-5c2f-410a-8fb4-8b3bc0f81e55 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 124351b2-6dbf-42d0-9ea7-f0e299215f9a | Product name | 1 | 20210115 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58466-109-03 | 2025-07-25 | C162847 | 48780-1 | 2cef2736-9a18-d83d-e063-dadaa90ab31f | 78 x 36 SPF 30 Active |
| 58466-109-03 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9a18-d83d-e063-dadaa90ab31f | 78 x 36 SPF 30 Active |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58466-109-03 | 78 x 36 SPF 30 Active | 96 g in 1 TUBE | CREAM | 96 | 2 | |
| 58466-109-03 | 78 x 36 SPF 30 Active | 1 in 1 CARTON | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| MISTINE UV DEFENSE FACE MOISTURIZER SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a9303-662f-9614-e063-6294a90a6b51 | 2026-02-24 | Warnings | M020 |
| SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9ac780-ef7d-42fc-e063-6394a90ad62f | 2026-02-24 | Warnings | M020 |
| PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50 | SUNSCREEN | Saltair Body LLC | 4b9b36a6-4da9-8439-e063-6394a90aa86b | 2026-02-24 | Warnings | M020 |
| SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | Shiseido Americas Corporation | b93f10dc-193d-4cda-94b6-3f0e54d89f21 | 2026-02-23 | Warnings | M020 |
| cle de peau BEAUTE ADVANCED PROTECTIVE DAY | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 710975d8-43bf-40b9-82c2-d4dc2988956d | 2026-02-23 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR MINERAL | TITANIUM DIOXIDE AND ZINC OXIDE | SHISEIDO AMERICAS CORPORATION | 5e31eee8-6532-47ea-99fc-22418791804b | 2026-02-23 | Warnings | M020 |
| Eryfotona Ageless | ZINC OXIDE | ISDIN Corp. | a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f | 2026-02-23 | Warnings | M020 |
| Perfect Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN PERFECT MEDICAL | 4b47e7cb-17d6-6a7c-e063-6294a90abbea | 2026-02-20 | Warnings | M020 |
| Beauty Hydrating | HOMOSALATE, ZINC OXIDE | Meijer, Inc. | 69b72139-757f-476d-99d2-33f5524c41d2 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| daily moisturizer | AVBENZONE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | 6d301146-46e0-445c-b14e-3ec8ce76cb45 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Meijer, Inc. | e9f4a2bb-d21e-4b38-9a37-23c23c8ad857 | 2026-02-19 | Warnings, Adverse reactions | M020 |
| Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut Scent | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Ink-eeze | 3f759bec-4e33-46fa-a800-fa3a17d63df9 | 2026-02-19 | Warnings | M020 |
| Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42 | TITANIUM DIOXIDE, ZINC OXIDE | ALLAY SKIN SOLUTIONS LLC | 425bf1d7-f2cf-4237-9047-dd53054acd1c | 2026-02-18 | Warnings | M020 |
| e.l.f. Best and Obsessed Skincare Set | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 4b1c1150-5ac5-4a8b-e063-6394a90a5410 | 2026-02-18 | Warnings | M020 |
| Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARIN | TITANIUM DIOXIDE | S.A. COMPTOIR NOUVEAU DE LA PARFUMERIE | dacff3dc-49d7-6416-e053-2a95a90a85c6 | 2026-02-18 | Warnings | M020 |
| Degree Clinical | COOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANT | Conopco Inc. d/b/a/ Unilever | 4b1f9fd3-3c49-9a98-e063-6294a90a20e0 | 2026-02-18 | Warnings | M020 |
| e.l.f. Wake the E.L.F. Up Skincare Set | AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE | e.l.f. Cosmetics, Inc | 4b20c56a-3e91-3419-e063-6294a90ad361 | 2026-02-18 | Warnings | M020 |
| Dermatone Mineral SPF 30 | ZINC OXIDE 20% | Dermatone Labs LLC | 26e3209f-cb5c-484e-9b2e-74dc397d4790 | 2026-02-18 | Warnings | M020 |
| SHISEIDO ESSENTIAL ENERGY HYDRATING DAY | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | SHISEIDO AMERICAS CORPORATION | 8b88039a-09fe-458b-b80f-49cde49b6595 | 2026-02-17 | Warnings | M020 |
| cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f3729d0b-e601-48bb-9907-1d6e3ab31996 | 2026-02-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 58466-109-03 | 58466010903 | 1 TUBE in 1 CARTON (58466-109-03) / 96 g in 1 TUBE | 1 tube | 2023-10-01 | No | No | Current |