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 | 2026-11-13 | ||
| excluded package | package | 61354-082 | 61354-082-01 | I | Inactivated by FDA | 2026-11-13 |
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 |
|---|---|---|---|---|---|---|
| CVS Health Sport SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f799bad7-b3df-f9a5-e053-6294a90ab104 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f41e145c-896e-2782-e053-2995a90a5f81 | 2024-10-17 | Warnings | M020 |
| CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTOCRYLENE, ZINC OXIDE | CVS PHARMACY | f9c89108-1568-ee3e-e053-6294a90ac756 | 2024-10-17 | Warnings | M020 |
| CVS Health 50 Clear Zinc Broad Spectrum SPF 50 Sunscreen | OCTOCRYLENE, ZINC OXIDE | CVS PHARMACY | fa19e9d3-6ab8-cbd6-e053-6294a90aae9b | 2024-10-17 | Warnings | M020 |
| CVS Health Sport 30 Clear | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | CVS PHARMACY | fbe6ae15-28ef-2acf-e053-6394a90a8d42 | 2024-10-17 | Warnings | M020 |
| CVS Health 45 Ultra Sheer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | fc4addf0-9a6e-292f-e053-6294a90ab9c0 | 2024-10-17 | Warnings | M020 |
| CVS Health Sport 70 | AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | fc4a79ce-208e-2aed-e053-6394a90a06bb | 2024-10-17 | Warnings | M020 |
| CVS Health Sport 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | CVS PHARMACY | fc4bbb80-c3f6-c4f7-e053-6394a90a4cae | 2024-10-17 | Warnings | M020 |
| SPF 50 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | DEMOULAS SUPER MARKETS, INC | ee782436-9eff-49e4-8edc-fd9783454c07 | 2024-10-17 | Warnings | M020 |
| GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45 | AVOBENZONE, HOMOSALATE, OCTISALATE | Aramara Beauty LLC dba Glow Recipe | 0c437f88-c731-5834-e063-6394a90a3299 | 2024-10-17 | Warnings | M020 |
| SPF 30 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | DEMOULAS SUPER MARKETS, INC | 5ce3e436-37d1-4918-bb14-0be33b0bc86a | 2024-10-17 | Warnings | M020 |
| MARKET BASKET KIDS SPF 50 SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | DEMOULAS SUPER MARKETS, INC. | a6a381da-6e34-bffe-e053-2a95a90a46f2 | 2024-10-17 | Warnings | M020 |
| Market Basket Continuous Sunscreen SPF 50 | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | DEMOULAS SUPER MARKETS, INC. | f4238107-c76c-266a-e053-2a95a90a8978 | 2024-10-17 | Warnings | M020 |
| Market Basket Continuous Sunscreen General Protection SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | DEMOULAS SUPER MARKETS, INC. | e7182d07-a006-db4b-e053-2995a90aa9e1 | 2024-10-17 | Warnings | M020 |
| EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Army & Air Force Exchange Service | e467df80-9007-46c9-e053-2a95a90a1bef | 2024-10-17 | Warnings | M020 |
| EXCHANGE SELECT KIDS SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Army & Air Force Exchange Service | e467c306-a2ed-4976-e053-2995a90a56ed | 2024-10-17 | Warnings | M020 |
| Exchange Select Sport Sunscreen Continuous SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | Army & Air Force Exchange Service | e716ba8c-0148-07f2-e053-2a95a90a53df | 2024-10-17 | Warnings | M020 |
| EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Army & Air Force Exchange Service | f55828b4-f2a4-13ec-e053-2995a90a0f84 | 2024-10-17 | Warnings | M020 |
| SPF50 Plus Mineral Sunscreen | ZINC OXIDE AND TITANIUM DIOXIDE | KAS Direct LLC dba BabyGanics | 08e8bc10-85d8-4215-8351-7ec12029416c | 2024-10-17 | Warnings | M020 |
| bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus Scent | OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Bu Brands, LLC | 9ac92c96-5bcf-421d-9cd0-73ddfa10195c | 2024-10-17 | 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 |