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 firm2026-11-06
excluded packagepackage45334-33145334-331-03DDiscontinued by firm2026-11-06

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.

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 321 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gin Amber Beauty Mineral Sunscreen Broad Spectrum SPF 25 BB CreamZINC OXIDEGin Amber Beauty LLC32f48fe4-5788-449e-9ed8-9cd8b2ecc1c02023-11-14WarningsExact identifier
application number: M020
Private Label SPF 50 80 min Water ResistantHOMOSALATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC8849fa88-24c8-410d-b16e-60da38288f982023-11-14WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50ZINC OXIDEGalderma Laboratories, L.P.0d09b812-b3ca-4214-bed7-7e21ee3288b72023-11-14WarningsExact identifier
application number: M020
DAYWEAR ADVANCED MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF15AVOBENZONE, HOMOSALATE, OCTISALATEESTEE LAUDER INC0a0bfe4a-53b6-5b7c-e063-6394a90a23ec2023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50 Mosquito Coast Sunscreen Plus Inspect RepellentAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBULLFROG BRANDS, LLC.f70b39c6-9f40-f5c1-e053-6394a90a1d432023-11-13WarningsExact identifier
application number: M020
Bull Frog SPF 50AVOBENZONE 3.00% HOMOSALATE 15.00% OCTISALATE 5.00% OCTOCRYLENE 10.00%Bullfrog Brands, LLCc90fc29e-d9fe-a6c9-e053-2995a90a69b32023-11-13WarningsExact identifier
application number: M020
Tropical Sands, SPF-50 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.493551d0-10a0-3d78-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.494a7886-d677-1648-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.ab691543-e37a-487a-912e-56d2e0e4d30a2023-11-11WarningsExact identifier
application number: M020
LBri Pure nNatural Oil Free MoisturizerOCTINOXATE, AVOBENZONE, OCTISALATEL'Bri Health & Beauty47f6ab9e-fa47-496a-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
PURE HAVEN BODY SPF 30TITANIUM DIOXIDE, ZINC OXIDEPure haven, LLC6f298fcd-8a97-8f66-e053-2991aa0adb102023-11-11WarningsExact identifier
application number: M020
Sunstation All-Natural SPF 30 SunscreenTITANIUM DIOXIDE, ZINC OXIDESunstation USA, LLC499d366a-a7f1-6070-e054-00144ff88e882023-11-11WarningsExact identifier
application number: M020
PURE HAVEN Face Sunscreen SPF-30ZINC OXIDEPure Haven, LLC1fff88a0-4d23-4cd7-872e-1a0b8c6803422023-11-11WarningsExact identifier
application number: M020
Pure Haven EssentialsTITANIUM DIOXIDE, ZINC OXIDEPure Haven LLC4bccc017-266d-11ce-e054-00144ff8d46c2023-11-11WarningsExact identifier
application number: M020
No BS SPF20 MoisturizerOCTINOXATE, AVOBENZONE, OCTOCRYLENEProduct Management LLC690f68fa-d110-4a75-9a14-04aac1be45842023-11-11WarningsExact identifier
application number: M020
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDEKapa'ihi, Inc66e5eb1b-4ef0-459d-8428-b3e2f221bc852023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 PARTY CAKEOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC8cfaf1b6-0f25-4770-9760-2440b2c153b72023-11-11WarningsExact identifier
application number: M020
Sea Star Sparkle SPF-50 VERY BERRYOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEMJ Products Association, LLC88c403ea-7c78-423e-b05e-1e17c21c5a532023-11-11WarningsExact identifier
application number: M020
FITGLOW Vita Shield Hyaluronic Primer SPF-30ZINC OXIDEFITGLOW BEAUTY LLCb9ba7783-74ca-4736-8a60-1692158590472023-11-11WarningsExact identifier
application number: M020
BLUE MONARCH Tinted SPF-50 (Rose Gold)ZINC OXIDEBlue Monarch, LLC9ba00a03-1015-4946-8c9b-5ef377a32e4b2023-11-11WarningsExact 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