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 201 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Counter Beauty Dew Skin Tinted Moisturizer No. 1ZINC OXIDEG2G Ventures, PBC3a2676ed-087d-f957-e063-6294a90ad4572025-07-17WarningsExact identifier
application number: M020
Sjolie Tanning SPF 30 SunscreenZINC OXIDESJOLIE, INC.3a283a09-2edb-f92c-e063-6294a90a82bd2025-07-17WarningsExact identifier
application number: M020
Neutrogena Clear Body Breakout Free Oil Free Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC32889c1e-d539-4b36-b012-9789c4a8d6422025-07-16WarningsExact identifier
application number: M020
GZE Tinted SunscreenZINC OXIDE 3%Guangzhou Yilong Cosmetics Co.,Ltd.182612d8-76a4-44a1-e063-6394a90a8d5f2025-07-15WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC089b798b-829f-aa86-e063-6294a90a86312025-07-15WarningsExact identifier
application number: M020
MO HANDSOME Protection Sport Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE8 PINE DESIGN LLC982ada30-5f87-42c6-b9ea-fedd842aa09d2025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
application number: M020
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUNSTICKAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTYL SALICYLATEDONGDONGGURIMOO CO.,LTD.39eea41c-8703-cf1f-e063-6394a90a5b1f2025-07-14WarningsExact identifier
application number: M020
Basin Vanilla SPF 30 Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONERetail Concepts of Minnesota, Inc.4a8e7be0-97a6-ada5-e063-6294a90ae25a2025-07-14WarningsExact identifier
application number: M020
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact identifier
application number: M020
KLARINA Sheer Mineral Sunscreen Blender SPF 50ZINC OXIDEKLARINA INC081941e3-02da-43a2-bf6f-a6d0f053272f2025-07-10WarningsExact identifier
application number: M020
ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEATHLETIC COSMETIC COMPANY LLCf143a8e0-b32b-4b14-a6ae-f013627b484c2025-07-10WarningsExact identifier
application number: M020
Venofye Orchard Bee Brilliance SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe2025-07-10WarningsExact identifier
application number: M020
Touch Anti-Aging SPF 30 MoisturizerZINC OXIDE, OCTINOXATE, AND OCTISALATEDiractions Capital LLC47ce948e-5848-43a1-880e-aeb78e9ad1b32025-07-10WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06f2ced8-273e-454f-92b4-2846f6674b372025-07-10WarningsExact identifier
application number: M020
SPF30 unseen sunscreen 01BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.398bb1f5-80ea-c589-e063-6294a90abefd2025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLESICOS ET CIE1ac50772-0bea-4a41-8300-03f65f0bed522025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLEL'Oreal USA Products Ince74a8c43-ec70-4de1-b2b5-0e89e40bfb402025-07-08WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact 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