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 | 2026-11-13 |
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 |
|---|---|---|---|---|---|---|
| MISSHA M Perfect Cover BB Cream SPF42 (No. 25) | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 604e7a49-7986-11ee-e053-2a91aa0a1bee | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB No 27 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | c4e16cec-c7db-4e5e-9d05-5d7afdb79091 | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB SPF42 No29 | OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 3fc90114-4cdf-273e-e054-00144ff8d46c | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB No 31 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 95862d15-d977-7276-e053-2995a90ab690 | 2024-12-05 | Warnings | M020 |
| MISSHA M Perfect Cover BB Cream SPF42 No. 25 | ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE | Able C&C Co., Ltd. | 9c6f48b1-007b-434f-b756-242e3390e9b7 | 2024-12-05 | Warnings | M020 |
| MISSHA ALL AROUND VITA C SUNSCREEN | ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE | Able C&C Co., Ltd. | 1a7ec673-328a-8924-e063-6294a90a2f3d | 2024-12-05 | Warnings | M020 |
| (Re)Setting Refreshing Mist SPF 40 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | d4d8f28d-cb00-298d-e053-2995a90a10eb | 2024-12-05 | Warnings | M020 |
| KEYS SOULCARE DAILY MOISTURIZER BROAD SPECTRUM SPF30 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 2ba71f81-54d0-4955-9bae-2b6e35c9c35f | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Glow Body SPF 45 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | db5f6bad-65ae-2b05-e053-2a95a90a8569 | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Glow Face SPF 45 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | d91bba06-fd9b-3eb5-e053-2995a90a6124 | 2024-12-05 | Warnings | M020 |
| Whoa Glow broad spectrum spf 30 sunscreen Sheer Bronze shimmer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 65de9491-8804-4e3b-90a7-9b253e34b7d3 | 2024-12-05 | Warnings | M020 |
| Whoa Glow broad spectrum spf 30 sunscreen Sheer Champagne shimmer sunlight | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc | 499e5352-fcc4-4434-96f2-4375816991c9 | 2024-12-05 | Warnings | M020 |
| Cay Skin Isle Sheen Sunstick SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Cay Skin, Inc. | 288c3aeb-01b2-ce39-e063-6394a90ad04a | 2024-12-05 | Warnings | M020 |
| Cay Skin MoBay Mineral Sunscreen Drops SPF 30 | ZINC OXIDE | Cay Skin, Inc. | 288d5456-98f3-a998-e063-6294a90a8366 | 2024-12-05 | Warnings | M020 |
| Solar Moisturizer SPF 30 | OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | Allure Labs, LLC | ef4d54bf-25f5-4261-9d3d-c42b0d892275 | 2024-12-05 | Warnings | M020 |
| Clear Clear Zinc Solar Protection SPF 30 | ZINC OXIDE | Allure Labs, LLC | 79a3c8e2-c4f2-4c00-8e94-494654ae91a2 | 2024-12-05 | Warnings | M020 |
| LAB SERIES DAY RESCUE DEFENSE BROAD SPECTRUM SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OXYBENZONE | Aramis Inc. | 8b206b6d-92e4-48bc-a40c-93ffdd635535 | 2024-12-05 | Warnings | M020 |
| Kids Broad Spectrum SPF 35 | ZINC OXIDE | Allure Labs, LLC | b72caf9b-46df-f30c-e053-2995a90a9b6d | 2024-12-05 | Warnings | M020 |
| CBD Blue Light Defense SPF 30 | ZINC OXIDE | Allure Labs | b63b99af-2ddb-3535-e053-2a95a90a65d5 | 2024-12-05 | Warnings | M020 |
| AHAVA CC SPF 30 | AVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | AHAVA - Dead Sea Laboratories Ltd | 2fa6249a-9614-455c-8e07-9b829f3b0c22 | 2024-12-04 | 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 |