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 |
|---|---|---|---|---|---|---|
| Refreshing Water Hydration Stick SPF 50 | AVOBENZONE OCTISALATE HOMOSALATE OCTOCRYLENE | COOLA LLC | 6da037f8-bedb-467a-b534-e44752120f2c | 2024-12-27 | Warnings | M020 |
| Nu Skin ageLOC Radiant Day Broad Spectrum SPF 22 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | NSE Products, Inc. | 649a9c28-bfd4-404c-90d5-5d0ea8c7b645 | 2024-12-27 | Warnings | M020 |
| Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 Sunscreen | TITANIUM DIOXIDE | L'Oreal USA Products Inc | 87496037-36ca-4c5f-973f-46626cf4096e | 2024-12-27 | Warnings | M020 |
| PORESCREEN SPF40 | ZINC OXIDE | Dermalogica, LLC. | 37a7362a-b251-4d3a-a957-65d8f338fa12 | 2024-12-27 | Warnings | M020 |
| COOLA Classic Face Sunscreen Fragrance-Free SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COOLA LLC | 12ff4689-f7e2-49db-8848-608c61b41ef0 | 2024-12-27 | Warnings | M020 |
| NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT | ZINC OXIDE | Bentley Laboratories, LLC | 6edd51e5-1c42-4e66-b5ca-abfea2dad8f8 | 2024-12-27 | Warnings | M020 |
| Tone Control Morning Cream SPF 15 | OCTOCRYLENE AND OCTISALATE CREAM | Bentley Laboratories, LLC | b4e3cd1c-ae42-4995-a314-96d24d328e41 | 2024-12-27 | Warnings | M020 |
| ZO Skin Health Sunscreen Plus Powder Broad-Spectrum SPF 45 (Light) | ZINC OXIDE | ZO Skin Health, Inc. | be25489e-c3bf-77c5-e053-2a95a90a30de | 2024-12-27 | Warnings | M020 |
| COOLA Classic Body Sunscreen Tropical Coconut SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | COOLA LLC | 55ad5d2f-a855-491e-a287-13689f8abff1 | 2024-12-27 | Warnings | M020 |
| RODAN and FIELDS UNBLEMISH | TITANIUM DIOXIDE, ZINC OXIDE | Bentley Laboratories, LLC | 2b3b6b62-364f-4aba-8024-3a73752b4c56 | 2024-12-27 | Warnings | M020 |
| Powerbright Moisturizer SPF 50 | OCTOCRYLENE, HOMOSALATE, AVOBENZONE, AND OCTISALATE | Dermalogica, LLC. | 02c731ee-c5cb-4158-9b1f-e826593c3526 | 2024-12-27 | Warnings | M020 |
| INVISIBLE PHYSICAL DEFENSE SPF30 | ZINC OXIDE | Dermalogica, Inc. | 2e5e6861-25ea-4605-8e59-41d852c002b7 | 2024-12-27 | Warnings | M020 |
| COOLA CLASSIC FACE SUNSCREEN Cucumber Broad Spectrum SPF 30 | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | COOLA LLC | dec3b0d1-f06e-4acf-8ba2-64167e774abc | 2024-12-27 | Warnings | M020 |
| Clearing Defense SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | Dermalogica, Inc. | 2388ae53-0a61-43c0-8936-c639887a5649 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c5efde-42e3-e4fc-e063-6394a90a491d | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d832-8d9a-e063-6394a90a4c69 | 2024-12-26 | Warnings | M020 |
| Morphe SPF 30 Broad Spectrum Sunsetter Setting | OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATE | COSMAX USA, CORPORATION | 0d34406f-9dd0-3909-e063-6394a90ab9f9 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c64cc0-be42-c210-e063-6394a90a6d9a | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c61c42-edda-1ebd-e063-6294a90aee13 | 2024-12-26 | Warnings | M020 |
| Buildable Blur | HOMOSALATE, OCTISALATE, ZINC OXIDE | COSMAX USA, CORPORATION | 06c62206-d839-8d9a-e063-6394a90a4c69 | 2024-12-26 | 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 |