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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	45334-331		D	Discontinued by firm		2026-11-06
excluded package	package	45334-331	45334-331-03	D	Discontinued by firm		2026-11-06

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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	45334-331-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	45334-331-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	45334-331-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	45334-331-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	45334-331-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	45334-331-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	45334-331-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	45334-331-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	45334-331-03	`0efc9e666f02…`	`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 276 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	20b32aae-7f8b-44ed-a3df-706054fd6883	2024-10-17	Warnings	Exact identifier application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural White Sage Scent	OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Bu Brands, LLC	d77be4d0-c08a-4d81-b5df-a9bae38e3b97	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH BLOOD ORANGE AND ESSENTIAL OILS SPF 8 DRY TANNING SUNSCREEN	HOMOSALATE, OCTISALATE	FRUIT OF THE EARTH, INC.	13325a2a-f7f8-4019-acbb-205fd5dd13a5	2024-10-17	Warnings	Exact identifier application number: M020
FOTE CABANA BEACH CLUB WITH MANUKA HONEY AND ESSENTIAL OILS SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	FRUIT OF THE EARTH, INC.	ae7951e9-54f6-4eab-81b6-a2b2c978851d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Clubwith Blood Orange and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7805f3c-5b95-73bd-e053-2a95a90a9984	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Manuka Honey and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7820ba9-7520-5139-e053-2a95a90ab92d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Blood Orange and Essential Oils SPF 30	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7916317-c6a2-2eda-e053-2995a90a1628	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Cabana Beach Club with Mentha and Essential Oils SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c790031d-5448-a998-e053-2a95a90a763e	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of The Earth Sun Town City Kids SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c79472ea-a367-1328-e053-2a95a90a22d5	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning Dry Oil SPF 8 Sunscreen	HOMOSALATE, OCTISALATE	Fruit of the Earth, Inc.	c7a94f68-a4d5-ec82-e053-2995a90a38fb	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7ba72c2-ea23-0bb9-e053-2a95a90a1d90	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c795cd2f-89dc-78e3-e053-2a95a90a9422	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7a4783f-477f-1524-e053-2995a90a5ad9	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 15 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7aaa185-8490-60ec-e053-2995a90adc0d	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Dark Tanning SPF 8 Sunscreen	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7aa1e58-f7b3-6b7f-e053-2995a90a957c	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7bbad46-5c52-9f1d-e053-2995a90ae139	2024-10-17	Warnings	Exact identifier application number: M020
Fruit of the Earth Sun Town City Baby SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Fruit of the Earth, Inc.	c7bdd7a3-2e88-d881-e053-2a95a90a2ef9	2024-10-17	Warnings	Exact identifier application number: M020
dermalogica dynamic skin recovery spf 50	SUNSCREEN	Dermalogica, LLC	051b77ab-6970-48e4-bbfd-c066178ea32e	2024-10-17	Warnings	Exact identifier application number: M020
Hyaluronic Moisturizer	OCTINOXATE, OXYBENZONE. AVOBENZONE	Bentley Laboratories LLC	88bd6dff-ba19-4f8f-9432-28398d24f1ab	2024-10-16	Warnings	Exact identifier application number: M020
EQUALINE SPORT CONTINUOUS SUNSCREEN SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	f13feba4-25d8-61d0-e053-2995a90aafa8	2024-10-16	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45334-331-03	45334033103	1 TUBE in 1 CARTON (45334-331-03) > 85 g in 1 TUBE	1 tube	2021-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VANICREAM Sunscreen Sport Broad Spectrum SPF35	Pharmaceutical Specialties, Inc.	2023-11-08	HUMAN OTC DRUG LABEL	5

Vanicream Sunscreen Sport Broad Spectrum SPF 35

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

openFDA label cross-check#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#