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 216 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
natural lip balm SPF15( Birthday cake) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3152bd5d-474f-e392-e063-6294a90aa9302025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Bubble Gum FlavoredLIP BALM SPF15 BUBBLE GUM FLAVOREDLS Promotions Inc3152bd5d-4750-e392-e063-6294a90aa9302025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Cocount Pina Colada) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31538f32-9f71-bd40-e063-6394a90a1cd82025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Birthday Cake flavoredLIP BALM SPF15 BIRTHDAY CAKE FLAVOREDLS Promotions Inc3153bc6a-8f60-ea37-e063-6294a90acd972025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Apple pie) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3153e1fe-1c43-def0-e063-6294a90a6b3a2025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Strawberry Shortcake flavoredLIP BALM SPF15 STRAWBERRY SHORTCAKE FLAVOREDLS Promotions Inc315402e4-c1ec-150f-e063-6294a90ae29e2025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Vanilla) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3154206c-00b3-e5e3-e063-6394a90afee82025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Passion Fruit) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31544568-c556-72b2-e063-6294a90ace912025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( Peppermint) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.31548583-ecc7-2e1e-e063-6394a90a24022025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( strawberry) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.3154b0f0-2025-4514-e063-6394a90a70c42025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Tropical Punch FlavoredLIP BALM SPF15 TROPICAL PUNCH FLAVOREDLS Promotions Inc3154ae45-e075-f53b-e063-6294a90aed5b2025-03-27WarningsExact identifier
application number: M020
Lip Balm SPF15 Passion Fruit flavoredLIP BALM SPF15 PASSION FRUIT FLAVOREDLS Promotions Inc31552e96-980c-8120-e063-6294a90af3da2025-03-27WarningsExact identifier
application number: M020
natural lip balm SPF15( tropical punch) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.315579e7-e1fb-d6f5-e063-6294a90af06a2025-03-27WarningsExact identifier
application number: M020
Shea MoistureNOURISHED AND RADIANT BROAD SPECTRUM SPF 30 SUNSCREEN FACE LOTIONConopco d/b/a/ Unilever3159be1c-9678-5b1a-e063-6294a90acd082025-03-27WarningsExact identifier
application number: M020
CeraVe Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc7d9e8c07-d295-4c8e-a52f-bdb509dc489b2025-03-27WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Mattifying Oil plus Pore Control SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC8d89ebf5-bcd5-4fde-a7d4-059023e00f332025-03-27WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Brightening SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC4ff8525a-4526-4acf-86c7-88f1f10732742025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 UnflavoredLIP BALM SPF15LS Promotions Inc3131632d-735c-6688-e063-6294a90a02392025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Chocolate Sundae flavoredLIP BALM SPF15LS Promotions Inc3142f352-ee65-47b5-e063-6394a90ada572025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Pina Colada flavoredLIP BALM SPF15 PINA COLADA FLAVOREDLS Promotions Inc31440153-e7ca-1327-e063-6294a90a562c2025-03-26WarningsExact 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