Cream
- Product NDC
- 61354-082
- Requested package NDC
- 61354-082-01
- 11-digit product format
- 613540082
- Labeler code
- 61354
- Product ID
- 61354-082_e724e10c-4f05-b03d-e053-2a95a90a754c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide, Titanium Dioxide
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-26
- Marketing end
- 0000-00-00
- Substance
- TITANIUM DIOXIDE; ZINC OXIDE
- Active strength
- 5 mg/100mg; mg/100mg
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
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 package | package | 61354-082 | 61354-082-01 | I | Inactivated by FDA | 2026-10-23 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61354-082-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b0b7-d83d-e063-dadaa90ab31f | SKIN TREAT TINTED MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-082-01 | Cream | 1 in 1 CARTON | LOTION | 1 | 1 | |
| 61354-082-01 | Cream | 100 mg in 1 TUBE | LOTION | 100 | 1 |
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 |
|---|---|---|---|---|---|---|
| luminous aqua sunscreen mist | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 29fc0c2b-8d10-8704-e063-6394a90ad504 | 2025-10-21 | Warnings | M020 |
| DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREEN | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | DEWYTREE CO. ,LTD | 2f1ca6e0-f689-57c7-e063-6394a90a3da5 | 2025-10-21 | Warnings | M020 |
| TOSOWOONG Rice Glow SunScreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | MANTONG Co., Ltd. | 3e9120fd-1c2f-1546-e063-6394a90a9e46 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Buff | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 857666da-2b4a-4a4a-aa25-ed6fd9b6a163 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Ivory | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V | 62031860-2e28-4b25-82bd-29b874b24d84 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Cocoa | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 40e6473a-8363-4503-bde0-6c151296fb34 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Golden Tan | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 7f4a185c-85c7-43bf-8695-c01a3aecec0d | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V | 383aabdf-3feb-4407-9d85-27c11cb3e78c | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Shell | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V | 4585b1c8-e477-44d7-a3ad-a9efc3d699b7 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Soft Ivory | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V | 1e9efb61-06ad-4d2d-a81d-46aba72f7514 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- Bisque | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V | ffc421e1-26eb-44e7-b03c-5fab761a51b2 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural Tan | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V | 3617d26e-a94c-4665-988b-95dbbc527017 | 2025-10-21 | Warnings | M020 |
| Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- Honey | HOMOSALATE, OCTISALATE, ZINC OXIDE | Distribuidora Comercial Jafra, S.A. de C.V. | 55be05c0-429a-4ae0-bb86-1120bb1905ff | 2025-10-21 | Warnings | M020 |
| Sun face protector sunscreen broad spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | b8e1ced7-dafa-c71e-e053-2995a90a9550 | 2025-10-21 | Warnings | M020 |
| Jafra Sun sunscreen broad spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | b9316e16-c571-4a5c-e053-2995a90ac6a8 | 2025-10-21 | Warnings | M020 |
| Jafra Sun tinted face protector sunscreen broad spectrum 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Distribuidora Comercial Jafra, S.A. de C.V. | b8df67f8-57d9-ddc1-e053-2995a90a50c6 | 2025-10-21 | Warnings | M020 |
| Sonni SunDay Invisible Defense | TITANIUM DIOXIDE, ZINC OXIDE | Sonni | 41ad9658-7906-d04c-e063-6394a90a4723 | 2025-10-21 | Warnings | M020 |
| Sonni SunDay Body Balm | TITANIUM DIOXIDE, ZINC OXIDE | Sonni | 41adca2e-cf69-ccd9-e063-6294a90a0dc0 | 2025-10-21 | Warnings | M020 |
| HAWAIIAN TROPIC | AVOBENZONE OCTISALATE OCTOCRYLENE | Edgewell Personal Care Brands LLC | 0b625d48-9632-0464-e063-6394a90a9adc | 2025-10-21 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Deep 530 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 940e0b2d-0b10-4534-ba36-e9980cead492 | 2025-10-21 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61354-082-01 | 61354008201 | 1 TUBE in 1 CARTON (61354-082-01) > 100 mg in 1 TUBE | 1 tube | 2022-08-26 | 0000-00-00 | No | No | Current |