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 336 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1TITANIUM DIOXIDEAmway Corp706e1504-fad7-44fa-9030-f5b948e3e79b2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1TITANIUM DIOXIDEAmway Corpb785af89-1134-4fc6-8388-c47c52d153e02023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2TITANIUM DIOXIDEAmway Corpdb24e10a-6957-4ce7-8b03-572caacc647a2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1TITANIUM DIOXIDEAmway Corpe7d8616d-3e79-4b5e-b05b-fbb506c0203d2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1TITANIUM DIOXIDEAmway Corpff387c87-4ada-41c6-b62b-07a1432137702023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1TITANIUM DIOXIDEAmway Corp48c0bb8b-2f89-465e-9ae6-98690a2f877c2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Buff L1W1OCTINOXATE, OXYBENZONEAmway Corp11a8cc16-33f1-43d1-9f35-aa0f6e70adf62023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 Multipack NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Productsf4ed9d7f-2d03-87d1-e053-2a95a90a3b4f2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chablis L1C1OCTINOXATE, OXYBENZONEAmway Corp8cdf7dcf-c2fa-4e41-8d56-c4f6cebe0a902023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Mink L6W1OCTINOXATE, OXYBENZONEAmway Corp429044b1-f7b8-4d1e-8360-0feb380161dd2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cream L1W2OCTINOXATE, OXYBENZONEAmway Corpe7e89303-f399-46c7-a029-c6d3d0a2dc4e2023-10-22WarningsExact identifier
application number: M020
Artistry Skin Nutrition BALANCING Matte DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCd4a87153-7ef0-4365-ad91-dced9b1d80552023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp830a748f-bb14-47f6-ab6f-48d8bd7063212023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition HYDRATING DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC06313228-7a79-48c5-8fd0-b210da6d037b2023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCbd4818b3-d5db-4812-96ec-1bd91aa1508b2023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp20c432e2-4c63-485b-9dd5-2bc73b6f42852023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - LightENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAccess Business Group LLC070f9538-4b36-471a-aa06-6669e9ecfdf02023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp40a82d20-b84b-4ae8-818d-1f503ceef5812023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC4a0af0e9-04da-4b5f-a57a-967bef7257892023-10-21WarningsExact 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