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 114 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kind Restore Tinted Mineral Sunscreen	ZINC OXIDE	POLISH BEAUTY	3980d278-c0f4-2c59-e063-6394a90aac37	2025-12-16		Exact identifier application number: M020
Solar Eclipse Extreme Sunscreen	ZINC OXIDE	ULTRAVIOLET SKINCARE LLC	36bfa691-48c0-8033-e063-6294a90ad899	2025-12-16		Exact identifier application number: M020
Kind Restore Moisturizing Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	POLISH BEAUTY	39814e27-4f3f-5ee6-e063-6394a90a941b	2025-12-16		Exact identifier application number: M020
Yoali SPF 40	ZINC OXIDE	YOALI STUDIO LLC	390b7f9c-bc04-80ec-e063-6294a90a4092	2025-12-16		Exact identifier application number: M020
Skin Defense Matte Tinted Sunscreen	ZINC OXIDE	Gentlehomme LLC	365eb727-3e7f-f1dd-e063-6394a90aa469	2025-12-16		Exact identifier application number: M020
Dr B Clinical Skin Care Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365da1f8-5250-7589-e063-6294a90a3e68	2025-12-16		Exact identifier application number: M020
Dr B Clinical Skin Care Non Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	NAIRA BABAIAN, M.D., P.A.	365d7564-3025-257b-e063-6294a90ad170	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	Gentlehomme LLC	365e7d8e-e3e0-4c08-e063-6294a90af415	2025-12-16		Exact identifier application number: M020
Daily Replenish mineral sunscreen	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	369896b1-f4b4-6201-e063-6394a90a5bca	2025-12-16		Exact identifier application number: M020
Zinc 20 mineral sunscreen face Plus body	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	36985373-22dd-2232-e063-6394a90a76fb	2025-12-16		Exact identifier application number: M020
Matte Defense Mineral Sunscreen non tinted	TITANIUM DIOXIDE, ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698090a-1639-00f9-e063-6394a90a7dd1	2025-12-16		Exact identifier application number: M020
Daily Replenish mineral sunscreen	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698d309-b9bf-e197-e063-6294a90af5a1	2025-12-16		Exact identifier application number: M020
Zinc 20 mineral sunscreen face Plus body	ZINC OXIDE	PURE VITALITY SKIN AND BODY, INC	3698f29e-5d80-94af-e063-6394a90a0489	2025-12-16		Exact identifier application number: M020
Tinted Mineral Primer SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	JOSEPHINA RAMIREZ	365cf2be-8862-3622-e063-6394a90ac4e3	2025-12-16		Exact identifier application number: M020
SANCTUARY Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CHAMPAGNE APOTHECARY LLC	365ca99c-c878-1f4b-e063-6394a90a1f53	2025-12-16		Exact identifier application number: M020
Tinted Mineral Defense SPF 40	ZINC OXIDE	JOSEPHINA RAMIREZ	365d299a-5886-5597-e063-6394a90a336c	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	MILL VALLEY DERMATOLOGY, INC.	3b171a89-c757-47a1-e063-6294a90a7a64	2025-12-16	Warnings	Exact identifier application number: M020
Tinted BB Cream	ZINC OXIDE	Eco Esthetics LLC	38f3e618-59e1-4504-e063-6394a90afa55	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	MADRE TIERRA, INC.	3f697463-d3db-7b73-e063-6394a90ac222	2025-12-16	Warnings	Exact identifier application number: M020
Non-Tinted Replenishing Daily Protection	ZINC OXIDE	MADRE TIERRA, INC.	3f69d6f3-454b-e60a-e063-6394a90a8781	2025-12-16	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	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