Home NDC 45334-331 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 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.
Historic NDC status page 1 of 1 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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.
Matched openFDA labels page 343 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 97e7ece8-a705-4988-ba52-6d3f11573521 2021-12-01 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 6a44f926-11b4-4bc4-8d5d-721a89c4f0cc 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS b58af664-b0fd-4585-8417-7c20954d7aff 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 7bbd1334-fae8-4274-b927-a099af764345 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 970571f9-3d6b-46ae-a668-745de1911fa2 2021-11-09 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 542e1b2e-f63c-466b-b5ac-6c147a0e9dec 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 21b65c12-6f67-4053-9508-6b2709cc1fb8 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 8ea4c470-ebd5-448e-b72a-ccd1113de0ab 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS fd9689a4-21d1-49f0-bf59-b8e1da72cd16 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS c23b6a87-8cf9-4be3-8306-2285e7e926c1 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS a93cb6c6-d7c2-43cc-a2e8-961f896a977e 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 32d99955-1593-426b-958e-5dcf689192a3 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 762deb57-754b-46a9-9907-de05e11da178 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3b5366e4-180a-4b98-9524-63601ae9d270 2021-11-08 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e 2021-11-04 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3e67abb5-84a4-4a78-9ea3-9fd57cbeb482 2021-11-04 Warnings Exact identifier application number: M020 No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 477d79c1-f169-4d0e-a95d-f5e832855f0d 2021-11-04 Warnings Exact identifier application number: M020 Anhydrous SPF 30 TITANIUM DIOXIDE, ZINC OXIDE Owen Biosciences, Inc. 1510cae2-9c8f-45ba-b088-67747af3d30c 2021-07-15 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS 3f0480e4-b2c3-962c-e063-6294a90a4f23 2021-07-13 Warnings Exact identifier application number: M020 No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory OCTINOXATE, TITANIUM DIOXIDE BCM Cosmetique SAS aa708db4-ad90-49b7-a250-5698e4c7d3d6 2021-07-13 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table 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