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 | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | a9068dc0-bc48-498b-adc9-57ff810384af | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 37f01f66-c604-4fc3-a263-2089db91283f | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | bca57893-bd2d-44ac-a503-2f11c3b62bf2 | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 37188b77-ab0b-4bea-b839-99e589600a2b | 2025-08-11 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | c89e45d6-2322-4913-a557-e1780a86fd63 | 2025-08-11 | Warnings | M020 |
| Sun Bum Face 70 Premium Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Sun Bum, LLC | 3c1ed89c-6d50-6400-e063-6294a90a1433 | 2025-08-11 | Warnings | M020 |
| NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 15mL with Pink Algae SPF 50 | ZINC OXIDE | NAKED SUNDAYS PTY LTD | 24e9ea4d-3073-c126-e063-6394a90a7c6e | 2025-08-10 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM PEACH SHAKE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | d1c5b7a5-73f9-4df6-9469-ce42e4f33ae8 | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM VANILLA LATTE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 96efeb92-a276-4ac9-b30a-11b4fa367263 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER PEACH SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | edeb2ee1-cc84-4254-80c1-6410cd77c422 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER STRAWBERRY SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 7abe936b-a4d5-457c-9cdd-761b201bb046 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER BLUEBERRY SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | e4eb80d8-e75c-4bb7-b3bc-9f05a0f23bab | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM CHOCO CAKE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 8be1c27c-7988-47c4-b613-3bc86f53981e | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM STRAWBERRY | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | a3c8d778-ce9c-46eb-a0c3-6886eb1d3934 | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE glow kiss TINTED LIP BALM CHERRY JUICE | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 6cdb0b61-a9c2-4a78-9752-8e7aedaeef45 | 2025-08-08 | Warnings | M020 |
| GOLDEN ROSE GLOW KISS TINTED LIP BALM BERRY PINK | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | f1b6c068-06d2-4a44-8199-7111d1b6a0d6 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER COOKIE SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 0274f5f1-1ee1-48a5-af7a-deb3aa3a34d7 | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER ICE MINT SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | a355777b-2cce-48ce-acc6-2aa7f154c4ba | 2025-08-08 | Warnings | M020 |
| GR LIP BUTTER RASPBERRY SPF 15 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 5443202c-4f88-4063-a227-c50abbd480d6 | 2025-08-08 | Warnings | M020 |
| SUNSCREEN SPF50 | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE | Guangzhou Tinsun Biotechnology Company Limited | 3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e | 2025-08-07 | 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 |