Vanicream Sunscreen Sport Broad Spectrum SPF 35
- Product NDC
- 45334-331
- 11-digit product format
- 453340331
- Labeler code
- 45334
- Product ID
- 45334-331_d9e0464f-e933-91dc-e053-2995a90a91b7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Pharmaceutical Specialties, Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2021-04-27
- Marketing end
- 0000-00-00
- Substance
- ZINC OXIDE
- Active strength
- 12 g/100g
- Pharmacologic classes
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- 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 | 45334-331 | D | Discontinued by firm | 2026-11-06 | ||
| excluded package | package | 45334-331 | 45334-331-03 | D | Discontinued by firm | 2026-11-06 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 45334-331-03 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 45334-331-03 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 45334-331-03 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 45334-331-03 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 45334-331-03 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 45334-331-03 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 45334-331-03 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 45334-331-03 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 45334-331-03 | 0efc9e666f02… | f202fb6c5f17… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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 |
|---|---|---|---|---|---|---|
| Intensive Age Defying Hydrating Complex SPF 25 | HOMOSALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE | June Jacobs Labs, LLC | 18f59d9d-1328-d815-e063-6294a90a3801 | 2024-05-21 | Warnings | M020 |
| Advanced Sun Resistance SPF 30 | HOMOSALATE, OCTINOXATE, OXYBENZONE, OCTISALATE, AVOBENZONE | June Jacobs Labs, LLC | 18f879f0-3d5b-0067-e063-6394a90a9db3 | 2024-05-21 | Warnings | M020 |
| Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs LLC | 18e1edd9-e39b-c91f-e063-6394a90a32a0 | 2024-05-20 | Warnings | M020 |
| Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE, ZINC OXIDE | June Jacobs Labs, LLC | 18e4c50d-eb91-c269-e063-6394a90a7999 | 2024-05-20 | Warnings | M020 |
| Broad Spectrum SPF 30 Tropical Sunscreen | BROAD SPECTRUM SPF 30 TROPICAL SUNSCREEN | Raining Rose, Inc | 18e7fc6b-b40a-f790-e063-6294a90ad0f4 | 2024-05-20 | Warnings | M020 |
| Protectif Untinted | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 18aa2604-c8f0-ca04-e063-6294a90a1c25 | 2024-05-17 | Warnings | M020 |
| Vacation Shimmer Oil | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | Vacation Inc | 150cbb23-fcb9-ed6f-e063-6394a90a597c | 2024-05-16 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Tinted Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66dfcec-ad40-3a0b-e053-2995a90aa006 | 2024-05-14 | Warnings | M020 |
| Babo Botanicals Daily Sheer Fluid Mineral Sunscreen SPF 50 | ZINC OXIDE | Babo Botanicals, Inc. | d66c88a1-7684-1043-e053-2a95a90aa2aa | 2024-05-14 | Warnings | M020 |
| Jack Black | TITANIUM DIOXIDE, ZINC OXIDE | Jack Black L.L.C | 181d5bf3-ce91-cb2c-e063-6294a90a51c4 | 2024-05-10 | Warnings | M020 |
| Protectif Fair Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 181e3f34-c5b2-0976-e063-6394a90a9a78 | 2024-05-10 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-30 | ZINC OXIDE | SABIYA, LLC | bc403672-7576-49a6-9a29-4f6cb19af7a4 | 2024-05-09 | Warnings | M020 |
| SABIYA Broad Spectrum SPF-50 | ZINC OXIDE | SABIYA, LLC | 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c | 2024-05-09 | Warnings | M020 |
| Protectif Deep Tint | ZINC OXIDE AND TITANIUM DIOXIDE | Allure Labs | 180b2939-5ae4-88fb-e063-6394a90aad93 | 2024-05-09 | Warnings | M020 |
| UV Daily Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | c12fa9a4-d7e5-46bf-9bfb-1cbbaa73b450 | 2024-05-09 | Warnings | M020 |
| Chemical Sunscreen SPF50 | OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE SUNSCREEN | Swiss-American CDMO, LLC | 50f47495-93aa-4e11-a153-d4c847a36c99 | 2024-05-08 | Warnings | M020 |
| UV Clear Deep Tint | OCTINOXATE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc. | ead07d51-9400-4f0a-8966-7052dfae67bc | 2024-05-08 | Warnings | M020 |
| Essence Pout Protector SPF 20 Lip Balm | HOMOSALATE, OCTISALATE, ZINC OXIDE | cosnova GmbH | 17e483c5-6e47-9a50-e063-6394a90aa604 | 2024-05-07 | Warnings, Adverse reactions | M020 |
| MIRABELLA Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTISALATE, AVOBENZONE | GDM ENTERPRISES LLC | 3ac847d5-a75d-4b32-84e1-70e4282c0d72 | 2024-05-06 | Warnings | M020 |
| MELAN SPF-30 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE | MELAN INC. | 75fcef12-bc33-44a7-acda-77d5d7bca2bc | 2024-05-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45334-331-03 | 45334033103 | 1 TUBE in 1 CARTON (45334-331-03) > 85 g in 1 TUBE | 1 tube | 2021-04-27 | 0000-00-00 | No | No | Current |