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 | 2026-10-23 | ||
| excluded package | package | 61354-084 | 61354-084-01 | 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 | 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 |
|---|---|---|---|---|---|---|
| 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 |
| Lipid Shield SPF 30 | ZINC OXIDE | Allure Labs | 3bce820a-147b-5d8b-e063-6294a90a570d | 2025-08-07 | Warnings | M020 |
| GR LONGSTAY Matte Face Powder SPF 15 | OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 62759398-4935-4732-b950-cfbeab82bc5a | 2025-08-07 | Warnings | M020 |
| Neutrogena Ultra Sheer Dry-Touch Sunscreen MAX Broad Spectrum SPF 100 Plus | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | 3bac8d0a-8726-46c3-e063-6294a90a1075 | 2025-08-06 | Warnings | M020 |
| Tanning Club Golden Glow Tanning Oil SPF 15 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | TANNING CLUB, LLC | 33478e28-b079-4e52-9924-845d127be286 | 2025-08-06 | Warnings | M020 |
| Tanning Club Everyday Sunscreen SPF 30 | HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | TANNING CLUB, LLC | 805048c4-f2b3-4d35-8674-f44cf3d1a4b5 | 2025-08-06 | Warnings | M020 |
| PoolBar I Scream For Sunscreen SPF 50 Coconut and Vanilla | AVOBENZONE, OCTISALATE, OCTOCRYLENE | POOLBAR | deddb91d-b2d5-4d97-bc38-5c11abde9d43 | 2025-08-06 | Warnings | M020 |
| PoolBar I Scream For Sunscreen SPF 30 Coconut and Vanilla | AVOBENZONE, OCTISALATE, OCTOCRYLENE | POOLBAR | 7f16b91d-29e4-4c21-a008-5dcc858c83d8 | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 17W Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 053cb3cd-dd16-4d08-b347-a4349fa37c07 | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 7bf90657-b636-41d6-b96c-88d174989f5b | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | da7e19cd-6a8b-47df-bfc9-2f0f11b7955c | 2025-08-06 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | f7a1d379-6de0-4be4-84a9-e0ebef332bef | 2025-08-06 | 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 |