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 |
|---|---|---|---|---|---|---|
| Eucerin Sensitive Mineral SPF 50 Sunscreen | ZINC OXIDE | Beiersdorf Inc | cdb25154-e4e3-efc7-e053-2a95a90a2df6 | 2025-11-10 | Warnings | M020 |
| ESSENCE BY CATHERINE HINDS Broad Spectrum MINERAL PROTECTION SPF 50 | ZINC OXIDE | Catherine Hinds Company, Inc. | 956e6643-51c9-49c4-bd68-f5ee1b0ae4e0 | 2025-11-10 | Warnings | M020 |
| GoodSense SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c85d59a1-6ae1-bb2e-e053-2995a90af20e | 2025-11-09 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 6% | Geiss, Destin, & Dunn, Inc. | c85c5d2b-35f6-2fd5-e053-2995a90a4a53 | 2025-11-09 | Warnings | M020 |
| Walgreens SPF 50 Tinted Mineral Fluid | TITANIUM DIOXIDE | Walgreens | 345918e3-95f8-404c-e063-6394a90a3fca | 2025-11-09 | Warnings | M020 |
| Gold Dynamics Skin Boosting Moisturizer Broad Spectrum SPF 15 Sunscreen | AVOBENZONE, OXYBENZONE, OCTISALATE, OCTINOXATE | Distribuidora Comercial Jafra, S.A. de C.V. | ad6646c7-c6aa-4610-a0c7-ddd1ddd13cde | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 500 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | d690d5d1-e1fa-404f-a17e-7b97be17b44a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 510 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2fbdeff7-4880-49ef-bb4d-e033d18e0459 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 540 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6a86e5fd-6736-45e0-aa7d-d268fdaed4f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Deep 560 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 42a3625f-5c58-4ec5-895f-b14f74428271 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 415 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8e14fe81-cf7f-4a81-afec-e6c8466179c9 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 425 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 7dd9f4cb-78d8-4edc-a63c-d4a02930a0f8 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC Cream SPF 30 Tan 450 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8acb660f-94bd-4c4f-b0c1-3682cf8ed543 | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC SPF 30 Fair 150 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | fad2bec7-c5f4-45f4-aff4-a5022033cb6a | 2025-11-07 | Warnings | M020 |
| e.l.f Camo Semi-Matte CC SPF 30 Medium 355 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 39856c69-84fb-4b12-a713-8912263e42b1 | 2025-11-07 | Warnings | M020 |
| e l f Holy Hydration Face SPF 30 Sunscreen, | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 44a8028b-731d-4561-b2e3-ee9738ad8d30 | 2025-11-07 | Warnings | M020 |
| e l f Sun Boss Gloss SPF 25 Sunscreen Its your Mauve | ZINC OXIDE | e.l.f. Cosmetics, Inc. | bce21361-c92c-40ad-a373-db3b83b15b8a | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Bronze Shimmer Sunburst | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 49d912c7-259a-487d-a523-b14031bfaab6 | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Champagne Shimmer Sunlight | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 1e9bdd41-69c3-4034-bd9e-b4bc5a1bd50d | 2025-11-07 | Warnings | M020 |
| e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer Sunbeam | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | f818f524-0263-4f89-b4f3-4dd83d688e7e | 2025-11-07 | 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 |