Cream
- Product NDC
- 61354-082
- 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 product | product | 61354-082 | I | Inactivated by FDA | 2026-10-23 | ||
| excluded package | package | 61354-082 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 | 61354-082-01 | 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 |
|---|---|---|---|---|---|
| 61354-082-01 | 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 |
|---|---|---|---|---|---|---|
| e l f Camo Semi Matte CC SPF 30 Light 210 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 2f151e6c-ab2d-40cb-a67c-e067147ed702 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 280 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 6b0b9204-f205-415b-bd16-1970958b8be7 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 240 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8c12a34c-f648-4b55-8265-d430c72ae205 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Light 250 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 0b1c20e6-9d98-4b69-8fe0-ac5e9f2b9b2c | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 370 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b8d4862e-2671-4b85-8338-f935e0d0194f | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 310 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 8d53abee-73bc-4268-b08d-0c196ff4d852 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Medium 375 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 1de296f5-276b-4e8f-8db2-78ea01965c4a | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 610 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 75543b93-8ed9-4c7b-9fcf-99745df5a194 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 620 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 798eecb3-ff6e-46d1-9053-b40e9cd02e5c | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 640 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | cbf949b3-e640-48eb-acf6-fccd6f258865 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 650 C | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | b8bfad36-54b7-42f3-bb5b-5eda1a10f021 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Rich 660 N | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 853100ea-a9dc-43eb-9715-125b543d2be0 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Tan 400 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | e4f2b579-4886-4e20-a527-c033e9d60bf5 | 2025-10-31 | Warnings | M020 |
| e l f Camo Semi Matte CC SPF 30 Tan 460 W | ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 49255019-fa24-4667-b527-ef7189a51f12 | 2025-10-31 | Warnings | M020 |
| SEKKISEI HERBAL UV DEFENSE gel | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | KOS America, Inc. | cb0faa3a-68f8-49c5-8c28-3338b1b27cd8 | 2025-10-31 | Warnings | M020 |
| Perricone MD Hypoallergenic Clean Correction Ultra-Lightweight Calming SPF 35 Veil | ZINC OXIDE | THG Beauty USA LLC | 2c749a52-adaa-2609-e063-6294a90a8fc2 | 2025-10-30 | Warnings | M020 |
| ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF45 BROAD SPECTRUM | AVOBENZONE, HOMOSALATE, OCTISALATE | SEORIN COMPANY Co., Ltd. | 4260e410-d2d5-71b4-e063-6294a90a05b8 | 2025-10-30 | Warnings | M020 |
| Clove Hill Tinted Mineral Sunscreen SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Clove Hill LLC | eb2ff5a7-384f-4379-b149-47c1c8c2291d | 2025-10-30 | Warnings | M020 |
| Tinted Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Clove Hill LLC | a37db64d-8b79-40f4-843f-f38949c5b9d2 | 2025-10-30 | Warnings | M020 |
| WEIGHTLESS PROTECTION SPF 30 | OCTINOXATE, ZINC OXIDE, OCTISALATE | Botanical Science Technologies | de9a97b8-6633-4d71-e053-2995a90a5e8f | 2025-10-30 | 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 |