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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45334-331DDiscontinued by firm2026-10-12
excluded packagepackage45334-33145334-331-03DDiscontinued by firm2026-10-12

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45334-331-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45334-331-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45334-331-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45334-331-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45334-331-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45334-331-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45334-331-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45334-331-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45334-331-030efc9e666f02…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 22 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Unseen Sunscreen SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONESupergoop LLC21b3491f-7b02-9bc5-e063-6294a90a0dc32026-06-04WarningsExact identifier
application number: M020
Mineral Glowscreen Soft-Radiance Drops Golden HourZINC OXIDESupergoop LLC1f1be2a7-af96-d73d-e063-6394a90acc1a2026-06-04WarningsExact identifier
application number: M020
Play Antioxidant Body Mist WIth Vitamin C Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC975402e6-8c74-b18e-e053-2995a90a467e2026-06-04WarningsExact identifier
application number: M020
Derma E Sun Drops SPF 30ZINC OXIDEderma e76c29f24-e0d9-4235-b278-96e609bc58db2026-06-04WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCARE MILK GBZINC OXIDE OCTOCRYLENE ETHYLHEXYL SALICYLATE HOMOSALATE TITANIUM DIOXIDEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5354af18-50c4-5fba-e063-6394a90ace392026-06-03WarningsExact identifier
application number: M020
ATOMY BB SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b0cd27ee-4917-4800-bcdf-c6e14b28c1d12026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.ad0b9091-a990-45bf-93f4-d886be1bbffe2026-06-02WarningsExact identifier
application number: M020
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.994d5680-284e-4faf-a29b-4d28f8d46e8f2026-06-02WarningsExact identifier
application number: M020
BLDG Active Skin Repair Sun Stick Performance SunscreenZINC OXIDEInnovacyn, Inc.a751fc1d-5ee4-4ecc-8ade-2568d91890c42026-06-02WarningsExact identifier
application number: M020
ANESSA PERFECT UV SUNSCREEN SKINCAREHOMOSALATE OCTOCRYLENE ETHYLHEXYL SALICYLATEHONGKONG JIAHE INTERNATIONAL HOLDING LIMITED5347c9a1-2239-b617-e063-6294a90ac6012026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Hydro Booster Moisture SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEOlive International Co., Ltd.4ea2292a-571c-475c-a64c-cbdd1f51f2422026-06-02WarningsExact identifier
application number: M020
Sungboon Editor Daily Invisible Blurring SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOlive International Inc.42325963-0917-43c4-8fe0-130336c7fa812026-06-02WarningsExact identifier
application number: M020
Matte Veil Tinted Broad Spectrum Sunscreen SPF 40ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea8d60212-18a7-42af-8bb3-bfcff7690a492026-06-02WarningsExact identifier
application number: M020
The Mineral Melt SPF30ZINC OXIDE, TITANIUM DIOXIDEDune Suncare Inc.2114fc3b-c8ce-45d2-8a82-4dc54f0adaf32026-06-02WarningsExact identifier
application number: M020
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS UV AIR MINERAL SERUM SUNSCREEN BROAD SPECTRUM SPF 50TITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inca1acb789-5bf4-4447-b3c5-4a7d4d3013a72026-06-01WarningsExact identifier
application number: M020
4ocean REEF SAFE SUNSCREEN SPF 40ZINC OXIDEStream2Sea, LLC52d3d97c-a846-4721-acbe-52a525cb20112026-06-01WarningsExact identifier
application number: M020
APRILSKIN MUGWORT CALMING SUNSCREENOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAPR US INC50a7b64a-8b26-97ac-e063-6294a90ad77a2026-06-01WarningsExact identifier
application number: M020
Ultra Violette Future Screen Broad Spectrum SPF 50ZINC OXIDEGrace and Fire USA Inc.252fdc91-bbe2-58ec-e063-6294a90a50672026-06-01WarningsExact identifier
application number: M020
Ultra Violette Vibrant Screen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGrace and Fire USA Inc.2633a289-b3b2-b614-e063-6294a90ad2142026-06-01WarningsExact identifier
application number: M020
Ultra Violette Sequin Supreme SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEGrace and Fire USA Inc.41027faa-7d61-4970-e063-6294a90a7df42026-06-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45334-331-03453340331031 TUBE in 1 CARTON (45334-331-03) > 85 g in 1 TUBE1 tube2021-04-270000-00-00NoNoCurrent