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 |
|---|---|---|---|---|---|---|
| GR SATIN SMOOTHING Fluid Foundation SPF 15 | OCTINOXATE, OXYBENZONE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 1eba51f2-782e-480e-8555-f5ad8883fa0d | 2025-08-06 | Warnings | M020 |
| GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15 | OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 038ec45a-0d56-4cd9-8060-767b382c1237 | 2025-08-06 | Warnings | M020 |
| GR CC Broad Spectrum SPF 30 | OCTINOXATE, OXYBENZONE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 751d5194-f5ea-401b-9439-7770510a588c | 2025-08-06 | Warnings | M020 |
| GR NUDE LOOK SPF 25 | AVOBENZONE, OCTINOXATE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 96dae912-8fa5-4d0e-b873-e1dbb7398db0 | 2025-08-06 | Warnings | M020 |
| GR BB SPF 25 | OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE | ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI | 3b22579b-21ce-4b96-bd24-774ce35bf6f7 | 2025-08-06 | Warnings | M020 |
| Neutrogena Ultra Sheer Invisible Gel Face Sunscreen SPF 40 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 3b9a4bd9-cbe1-60c5-e063-6394a90a5892 | 2025-08-05 | Warnings | M020 |
| Neutrogena Hydro Boost City Shield water Broad Spectrum SPF 25 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | 77e4bbcc-0a51-4e9c-9328-46bcbf4f8129 | 2025-08-05 | Warnings | M020 |
| Aveeno Positively Radiant Daily Moisturizer Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | decb4842-c880-0668-e053-2995a90aad7e | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 08W Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 498bf941-67f2-41d5-a039-9f827b68297e | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 10N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 54e390bd-b84a-4c43-986e-74923e34689d | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 09C Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 897024cd-576e-4a8e-8daa-92dc3bb4b3a5 | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 11W Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 303967d1-9df8-4a8e-a264-6b0d8fdbf2a8 | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 12N Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 26062cd7-3817-46c7-b65f-92cd57eca5dd | 2025-08-05 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 13C Light Medium | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 448a24a3-91ef-4530-828c-e77d8aae7f0b | 2025-08-05 | Warnings | M020 |
| JORDAN FAT KIDS Tallow Sunscreen SPF 30 | MENTHOL, METHYL SALICYLATE | JORDAN FAT KIDS LLC | 72ac88cf-9f20-44ea-b3a2-12c922eec2b3 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 02C Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 09f9e59b-6f71-4d42-9b5d-275f756d985b | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 03W Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 3b1e4480-8409-425e-b98d-eb4dcf2471e8 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 06W Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | 3090422e-fc18-45b8-88f2-6a9b282a7205 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 05N Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | f93aa5d2-90ab-4e11-874e-2ede4b25c4b6 | 2025-08-04 | Warnings | M020 |
| Dolce and Gabbana Everlast Foundation SPF 20 04C Light | OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE | Dolce & Gabbana Beauty S.R.L | f055cd51-7b1d-43df-8990-8f60ba1eb91c | 2025-08-04 | 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 |