Cream
- Product NDC
- 61354-084
- 11-digit product format
- 613540084
- Labeler code
- 61354
- Product ID
- 61354-084_e7763ac1-d05c-7f8f-e053-2995a90a6c15
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide, Titanium Dioxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oxygen Development LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-08-30
- 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 product | product | 61354-084 | I | Inactivated by FDA | 2026-10-21 | ||
| excluded package | package | 61354-084 | 61354-084-01 | I | Inactivated by FDA | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61354-084-01 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 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 | 61354-084-01 | 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 | 61354-084-01 | 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 | 61354-084-01 | 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 | 61354-084-01 | 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 | 61354-084-01 | 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 | 61354-084-01 | 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 | 61354-084-01 | 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 |
|---|---|---|---|---|---|
| 61354-084-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-62bf-d83d-e063-dadaa90ab31f | TARTE high-performance naturals BB tinted treatment primer Broad Spectrum SPF 30 Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61354-084-01 | Cream | 100 mg in 1 TUBE | CREAM | 100 | 1 | |
| 61354-084-01 | Cream | 1 in 1 CARTON | CREAM | 1 | 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 |
|---|---|---|---|---|---|---|
| CVS SPF 60 Face Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS | 26d1b568-ad9c-80d7-e063-6394a90a2cbf | 2025-09-21 | Warnings | M020 |
| Radiant Shield Tinted Mineral Sunscreen SPF 40 | ZINC OXIDE | CosMedical Technologies, LLC | f229b928-49fd-4e02-99c1-b2cd9166894f | 2025-09-19 | Warnings | M020 |
| EquateDaytimeFaceLotion | EQUATE DAYTIME FACE LOTION WITH SUNSCREEN, SPF 30, 3 OZ | Walmart Inc. | 2efc7087-f4ad-2f2e-e063-6394a90a1302 | 2025-09-18 | Warnings | M020 |
| ERBORIAN CC RED CORRECT | ERBORIAN CC RED CORRECT SPF 25- OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE CREAM | Kolmask Co., Ld. | 09ca2d4b-e0c2-9961-e063-6394a90aa82e | 2025-09-18 | M020 | |
| ELROEL Pang Pang Sun Cushion Plus | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE | MONOGLOT HOLDINGS Inc. | 5ffaad65-f0b2-416a-b0a3-b92e880641e4 | 2025-09-18 | Warnings | M020 |
| e.l.f. Camo CC Cream SPF 30 Fair 125 C | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | e.l.f. Cosmetics, Inc. | 407f9c0d-31c6-f5bb-e063-6394a90a4db4 | 2025-09-18 | Warnings | M020 |
| Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | 1630feee-7e0d-c6f4-e063-6294a90a7b1c | 2025-09-17 | Warnings | M020 |
| Guise Tinted Drops | ZINC OXIDE | Donis Men LLC | 3f039049-5004-2888-e063-6294a90a5150 | 2025-09-17 | Warnings | M020 |
| ONE SIZE ON TIL DAWN | ONE SIZE ON TIL DAWN | Pogi Beauty LLC | 3f05d90b-9274-4d21-e063-6294a90a8485 | 2025-09-17 | Warnings | M020 |
| PUR 4-in-1 Skin Tint DP3 | ZINC OXIDE | PUR Minerals | 3f073413-b314-e5da-e063-6394a90a9ab4 | 2025-09-17 | Warnings | M020 |
| e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | e.l.f. Cosmetics, Inc. | 3fa7ef54-2c4d-9883-e063-6294a90a8d88 | 2025-09-17 | Warnings | M020 |
| CVS SPF 50 Face Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | CVS | 26a69a47-947a-a478-e063-6394a90aa468 | 2025-09-16 | Warnings | M020 |
| SkinSuit TM 3 in 1 Moisturizer SPF 50 | ZINC OXIDE | Skin Authority LLC | 5eb27be9-9e80-4f4a-b193-b918d831555d | 2025-09-15 | Warnings | M020 |
| Sun and Honey Tallow Sunscreen SPF 30 | ZINC OXIDE | Amara Ventures | 3eda8a70-7c9e-e920-e063-6394a90a85a2 | 2025-09-15 | Warnings | M020 |
| Klein Tools Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | KLEIN TOOLS, INC. | 3edcc26a-d960-3fa8-e063-6394a90ab703 | 2025-09-15 | Warnings | M020 |
| Klein Tools Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | KLEIN TOOLS, INC. | 3ede5e54-4c9f-02f7-e063-6294a90a9df6 | 2025-09-15 | Warnings | M020 |
| I.C. Industrial Sunscreen | ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE | R & R Lotion, Inc | b89d687a-7b36-4643-9817-765d4710ca60 | 2025-09-15 | Warnings | M020 |
| Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 97795f0e-d867-4e17-b7c9-ede08e7df70c | 2025-09-12 | Warnings | M020 |
| Oh My Bod Light Sunscreen Broad Spectrum SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Baxter Laboratories Pty. Ltd. | 3e9db4f5-d9d9-ddf3-e063-6394a90a99fc | 2025-09-12 | Warnings | M020 |
| Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep | ZINC OXIDE | DOLCE & GABBANA BEAUTY S.R.L. | 2d05659c-57d2-4faf-ab67-1b8d68945aed | 2025-09-12 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61354-084-01 | 61354008401 | 1 TUBE in 1 CARTON (61354-084-01) > 100 mg in 1 TUBE | 1 tube | 2022-08-30 | 0000-00-00 | No | No | Current |