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 | 2026-10-16 |
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 |
|---|---|---|---|---|---|---|
| NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30 | ZINC OXIDE | LABORATOIRES DRUIDE INC | 19af4441-31b2-72db-e063-6394a90a813c | 2026-01-14 | Warnings | M020 |
| Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30 | ZINC OXIDE | Sqween LLC | 9c3cf35b-4bde-46e3-8abd-5f4d1ad6e486 | 2026-01-14 | Warnings | M020 |
| SCENTUAL AROMA BEAUTY SUN VEIL SPF30 | TITANIUM DIOXIDE, ZINC OXIDE | LABORATOIRES DRUIDE INC | 0799ac38-9a41-6579-e063-6394a90ac4b6 | 2026-01-14 | Warnings | M020 |
| NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30 | ZINC OXIDE | LABORATOIRES DRUIDE INC | 0b412e24-baf6-e68e-e063-6394a90a5f49 | 2026-01-14 | Warnings | M020 |
| Dr. C. Tuna Sun Stick SPF 50 | AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | fc89d1b5-1ffe-4f06-8c5c-31f2eb0b5641 | 2026-01-14 | Warnings | M020 |
| Oiana Mineral Sunscreen Drops | ZINC OXIDE | Oiana LLC | 4860257d-a8bf-7ce5-e063-6394a90a74db | 2026-01-14 | Warnings | M020 |
| Standard Procedure Lip Balm SPF 50 | ZINC OXIDE HOMOSALATE OCTOCRYLENE | Standard Procedure Inc | 1e3db995-b1c5-3a2e-e063-6294a90af75e | 2026-01-14 | Warnings | M020 |
| Standard Procedure SPF 50 Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Standard Procedure Inc | 1d3f87de-90c0-75c0-e063-6394a90a2ef4 | 2026-01-14 | Warnings | M020 |
| EELHOE Bio Sun Stick | TITANIUM DIOXIDE | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 48654406-505b-518b-e063-6394a90a5add | 2026-01-14 | Warnings | M020 |
| JAYSUING Hyaluronic Acid Moisturizing Sunscreen | TITANIUM DIOXIDE | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 48662fae-2d41-4a4a-e063-6394a90a1522 | 2026-01-14 | Warnings | M020 |
| CALIFORNIA ALOE FRESH POW DERY SUN | HOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANE | NATURE REPUBLIC CO., LTD. | aa10dbbf-97b3-4258-bbd3-0d8cc9935e12 | 2026-01-13 | Warnings | M020 |
| COSRX | VITAMIN E VITALIZING SUNSCREEN | COSRX inc. | 4840f608-944a-3e3d-e063-6394a90a1d9d | 2026-01-13 | Warnings | M020 |
| Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 Plus | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Kenvue Brands LLC | b043f0f3-b263-4c49-86ca-9ecc71a22aa8 | 2026-01-13 | Warnings | M020 |
| ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30 | ZINC OXIDE | New Frontier Bio, Inc | ef6c8443-fd10-2022-e053-2a95a90a45ea | 2026-01-13 | Warnings | M020 |
| Bluevado Sunfix | ZINC OXIDE, TITANIUM DIOXIDE | Magic Blue, LLC | 2e5315bf-39f4-401c-8207-18ef6a97e024 | 2026-01-13 | Warnings | M020 |
| Intellishade TruPhysical SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | e20f5dc9-e863-b090-e053-2a95a90a5044 | 2026-01-13 | Warnings | M020 |
| Intellishade TruPhysical Clear SPF 50 | TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | 1305fa94-47d5-7a42-e063-6394a90a0aba | 2026-01-13 | Warnings | M020 |
| Intellishade Clear SPF 50 | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE | Revision, LLC | e213b46d-d061-dc83-e053-2995a90ad875 | 2026-01-13 | Warnings | M020 |
| Intellishade Matte SPF 45 | OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE | Revision, LLC | e213ae87-4db2-3070-e053-2995a90a083b | 2026-01-13 | Warnings | M020 |
| Sun Project Moisture | HOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANE | THANK YOU FARMER CO., LTD | 20a83f02-d851-4aac-e063-6394a90ae1a6 | 2026-01-13 | 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 |