PLUMSCREEN

Product NDC: 80476-101
11-digit product format: 804760101
Labeler code: 80476
Product ID: 80476-101_47d5defe-1b5d-7e14-e063-6294a90a4de8
Type: HUMAN OTC DRUG
Nonproprietary name: ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: Le Prunier Farms, Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-21
Substance: ZINC OXIDE
Active strength: 4.7 g/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: PLUMSCREEN
Brand name suffix: SPF 31
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	4.7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e20eb996-2b64-6bd0-e053-2a95a90a4f92	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80476-101-02	PLUMSCREENSPF 31	2 mL in 1 PACKET	CREAM	2	4
80476-101-10	PLUMSCREENSPF 31	10 mL in 1 TUBE	CREAM	10	4
80476-101-10	PLUMSCREENSPF 31	1 in 1 BOX	CREAM	1	4
80476-101-60	PLUMSCREENSPF 31	1 in 1 BOX	CREAM	1	4
80476-101-60	PLUMSCREENSPF 31	60 mL in 1 TUBE	CREAM	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80476-101	PLUMSCREEN SPF 31 (ZINC OXIDE) CREAM [LE PRUNIER FARMS, INC.]	3	Current NDC, Legacy NDC, 5 package rows	20240530_e20eb996-2b64-6bd0-e053-2a95a90a4f92.zip

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 313 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Coola Bare Republic Mineral Body Gel-Lotion SPF 30	ZINC OXIDE 18.2%	COOLA LLC	d745d12e-8741-4bf2-89ec-c6f72a8d548b	2023-12-20	Warnings	Exact identifier application number: M020
COOLA Classic Body Sunscreen SPF 70 - Peach Blossom	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA LLC	6efa0d9f-0ff3-4b2f-9587-9630261bcbd1	2023-12-20	Warnings	Exact identifier application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen light	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc	2023-12-20	Warnings	Exact identifier application number: M020
Coola Bare Republic Mineral Face Gel-Lotion SPF 30	ZINC OXIDE 18.2%	COOLA LLC	ad1614d4-5421-473d-a1e8-0ff18491df77	2023-12-20	Warnings	Exact identifier application number: M020
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Bentley Laboratories, LLC	4e0e426d-f037-428f-98f2-2d3e945bd040	2023-12-19	Warnings	Exact identifier application number: M020
COOLA Classic Body Sunscreen Fragrance-Free SPF 50	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Bentley Laboratories, LLC	57f2fdeb-2abc-4ad3-bb89-5faee883c0e5	2023-12-19	Warnings	Exact identifier application number: M020
Baby Bare Republic Mineral Sunscreen SoftStick SPF 50	ZINC OXIDE	COOLA LLC	1a603f62-86ec-4e66-a73f-718c5d012676	2023-12-19	Warnings	Exact identifier application number: M020
COOLA Classic Body Sunscreen Pina Colada SPF 30	AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE	Bentley Laboratories, LLC	d508cef6-977f-4231-8c19-491569e99921	2023-12-19	Warnings	Exact identifier application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - Hot	ZINC OXIDE 15%	Bentley Laboratories, LLC	a9e7a203-52f0-4a67-b3ea-65ff0968ec18	2023-12-19	Warnings	Exact identifier application number: M020
COOLA Refreshing Water Mist SPF 18	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Bentley Laboratories, LLC	658bf3fe-2246-40b6-8cb1-969bfdaffd1b	2023-12-19	Warnings	Exact identifier application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint Free - Cool	ZINC OXIDE 15%	Bentley Laboratories, LLC	cd80661f-348c-4bfd-a85c-041db1a1d0f4	2023-12-19	Warnings	Exact identifier application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - Warm	ZINC OXIDE 15%	Bentley Laboratories, LLC	d5fd3fea-5dcf-42ef-927a-3b4a3e1ccff8	2023-12-19	Warnings	Exact identifier application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutral	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	f5d54e9d-4963-419a-a091-bdbd1decd2b8	2023-12-19	Warnings	Exact identifier application number: M020
CHEVOURI Brightening Serum Broad Spectrum SPF-40	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	CHE'VOURI LLC	5a93d5f9-9313-4194-8c39-c513f5a85853	2023-12-18	Warnings	Exact identifier application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	9598949a-0dd6-4932-9dc8-354f9e10b601	2023-12-18	Warnings	Exact identifier application number: M020
BB blur tinted moisturizer Broad Spectrum SPF 30 light	TITANIUM DIOXIDE AND ZINC OXIDE	Tarte, Inc.	207aaa0c-777f-4abd-96b7-64666eb87f53	2023-12-18	Warnings	Exact identifier application number: M020
Valentino Very Valentino Light Lasting Perfecting Foundation Broad Spectrum SPF 26 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	69e0d803-be76-4cc3-bdeb-b50401d5d6d4	2023-12-18	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Deep	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	8bdd63f7-2f67-4280-9484-d6c8e80ad9b9	2023-12-16	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium Deep	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	8ab49def-c9cd-489e-a936-467067a88940	2023-12-16	Warnings	Exact identifier application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 Medium Deep	TITANIUM DIOXIDE AND ZINC OXIDE	Cosmetique Active Production	0cb8f22d-2343-415e-9f16-1791567864a1	2023-12-16	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
80476-101-02	80476010102	2 mL in 1 PACKET (80476-101-02)	2 ml	2024-01-04		No	No	Current
80476-101-10	80476010110	1 TUBE in 1 BOX (80476-101-10) / 10 mL in 1 TUBE	1 tube	2022-06-21	0000-00-00	No	No	Current
80476-101-60	80476010160	1 TUBE in 1 BOX (80476-101-60) / 60 mL in 1 TUBE	1 tube	2022-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LE PRUNIER - PLUMSCREEN SPF 31 (80476-101)	Le Prunier Farms, Inc.	2026-01-07	HUMAN OTC DRUG LABEL	4