Mineral Shake

Product NDC: 80641-014
11-digit product format: 806410014
Labeler code: 80641
Product ID: 80641-014_138cbcd0-ac5c-4e14-e063-6394a90af42c
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Vacation Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-03-07
Substance: ZINC OXIDE
Active strength: 20.5 g/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Mineral Shake
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	20.5 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
131b7e65-7155-f925-e063-6394a90a1d7a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80641-014-60	Mineral Shake	15 mL in 1 BOTTLE	LOTION	15		3
80641-014-75	Mineral Shake	50 mL in 1 BOTTLE	LOTION	50		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80641-014	MINERAL SHAKE (ZINC OXIDE) LOTION [VACATION INC.]	3	Current NDC, 2 package rows	20240315_131b7e65-7155-f925-e063-6394a90a1d7a.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 137 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Equate SPF 50 Sport Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Walmart Inc	45b4d41b-c9ac-2c26-e063-6294a90a614f	2025-12-11	Warnings	Exact identifier application number: M020
Mint Condition	ZINC OXIDE	Mint Skin Incorporated	353031d7-cc2d-426c-e063-6394a90a99ea	2025-12-11		Exact identifier application number: M020
Body Protect	ZINC OXIDE	Noble Center for Healthy Aging LLC	387df843-b7d3-df2e-e063-6294a90a93f2	2025-12-11		Exact identifier application number: M020
Everyday Mineral Tinted Sunscreen	ZINC OXIDE	Atlanta Acne Specialists, LLC	351e6ca8-c6cb-dd99-e063-6294a90af0cf	2025-12-11		Exact identifier application number: M020
Mint Condition	ZINC OXIDE	Mint Skin Incorporated	3530efd2-b122-9aba-e063-6394a90a8953	2025-12-11		Exact identifier application number: M020
The Tinted Mineral Sunscreen	ZINC OXIDE	The Hue Solution L.L.C.	37f30a04-8ffa-09de-e063-6294a90aba05	2025-12-11		Exact identifier application number: M020
Abib Airy clear sunscreen gel Smoothing tube	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Fourcompany Co., Ltd.	33d1a5da-68c3-b16e-e063-6294a90a7006	2025-12-10	Warnings	Exact identifier application number: M020
Non Tinted Mineral Moisturizing Sunscreen	ZINC OXIDE	ABOUT FACE AESTHETICS, INC.	3647a985-5365-a9e0-e063-6294a90ac0a4	2025-12-10		Exact identifier application number: M020
ProtectME Tinted Mineral SPF 40 20%	ZINC OXIDE	PUREFECTION LA, INC.	33dd1afa-25a8-891f-e063-6294a90a8c8a	2025-12-10		Exact identifier application number: M020
ProtectME Tinted Mineral SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	PUREFECTION LA, INC.	33dccd5d-8db1-f699-e063-6394a90a59a2	2025-12-10		Exact identifier application number: M020
Protect ME Non Tinted Mineral SPF 40	ZINC OXIDE	PUREFECTION LA, INC.	34a2d716-b853-752e-e063-6394a90a52e2	2025-12-10		Exact identifier application number: M020
Tinted Mineral Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ABOUT FACE AESTHETICS, INC.	364728b4-e0ff-8466-e063-6394a90a0089	2025-12-10		Exact identifier application number: M020
tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin & Bare It LLC	35d42661-e511-1dfc-e063-6294a90a9ed7	2025-12-10		Exact identifier application number: M020
non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Skin & Bare It LLC	35d3ef95-621c-f193-e063-6294a90ac3ee	2025-12-10		Exact identifier application number: M020
face Plus body sunscreen tinted	ZINC OXIDE	Skin & Bare It LLC	35d45df5-e9bf-1a08-e063-6294a90ae04f	2025-12-10		Exact identifier application number: M020
face Plus body sunscreen non-tinted	ZINC OXIDE	Skin & Bare It LLC	361ef750-0f0e-bd01-e063-6294a90a0020	2025-12-10		Exact identifier application number: M020
bare skin smooth mineral tint	ZINC OXIDE	Skin & Bare It LLC	361f2933-73d5-a9d7-e063-6394a90abb3c	2025-12-10		Exact identifier application number: M020
Smoothing Mineral Sunscreen Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DANIEL BEHROOZAN MD A MEDICAL CORPORATION	32721b87-aef1-d759-e063-6394a90a40d3	2025-12-10		Exact identifier application number: M020
Non-Tinted Mineral Stick	TITANIUM DIOXIDE, ZINC OXIDE	Shelley Bennett Skincare	326e9a14-5fb6-6a6e-e063-6294a90adece	2025-12-10		Exact identifier application number: M020
3-in-1 Daily Vanishing Tinted Sunscreen Cream	ZINC OXIDE	Shelley Bennett Skincare	325dae60-01cc-a120-e063-6294a90a2ef2	2025-12-10		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	Sample	Exclude flag	Status
80641-014-60	80641001460	15 mL in 1 BOTTLE (80641-014-60)	15 ml	2024-03-07	No	No	Current
80641-014-75	80641001475	50 mL in 1 BOTTLE (80641-014-75)	50 ml	2024-03-07	No	No	Current