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 20 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 50	OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND HOMOSALATE	Whole Foods Market, Inc.	82771f22-0197-40ba-97d2-2386152790ed	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SUNSCREEN CLEAR COCONUT VANILLA SPF 30	OCTOCRYLENE, OCTISALATE, AND AVOBENZONE	Whole Foods Market, Inc.	1c31f466-6a0d-46ce-9346-d2a0eb46c8d0	2026-06-15	Warnings	Exact identifier application number: M020
Shield by HEALTHY SKIN LAB MD SUNSCREEN	TITANIUM DIOXIDE, ZINC OXIDE	HEALTHY SKIN LAB LIMITED	6838b754-9915-48ff-af35-5338dbd06ac4	2026-06-15	Warnings	Exact identifier application number: M020
Solvyn Mineral Sunscreen SPF 50	ZINC OXIDE	Solvyn Skin LLC	b0a8d028-87d2-4339-8879-c62cbf8415f2	2026-06-15	Warnings	Exact identifier application number: M020
Amrit Ocean Resort Mineral Sunscreen SPF 50	ZINC OXIDE	Solvyn Skin, LLC	112364cd-a445-46c2-b2f3-f9705d682cf6	2026-06-15	Warnings	Exact identifier application number: M020
Kiss My Face Purely Mineral Face Factor 50 Sunscreen SPF 50	ZINC OXIDE	Windmill Health Products, LLC	9771aa6d-a797-42d5-919b-3bf67ef5e040	2026-06-15	Warnings	Exact identifier application number: M020
Cellular Swiss UV Protection Veil SPF30	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	La Prairie, Inc.	dd946a3b-74b9-4ebd-b82f-0350f8f72834	2026-06-15	Warnings	Exact identifier application number: M020
365 WHOLE FOODS MARKET SPORT MINERAL SPF 30	ZINC OXIDE	Whole Foods Market, Inc.	6caf656c-246f-469e-84f8-98f80b84c65e	2026-06-15	Warnings	Exact identifier application number: M020
EVIL GOODS TALLOW SUNSCREEN SPF50	ZINC OXIDE	Moes Group LLC	543058d4-f375-d702-e063-6394a90a2640	2026-06-14	Warnings	Exact identifier application number: M020
LASSO TALLOW SUNSCREEN SPF 50	ZINC OXIDE	Moes Group LLC	54312883-1d40-121e-e063-6294a90a247d	2026-06-14	Warnings	Exact identifier application number: M020
SFL SUNSCREEN - SOL DEFENSE SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Lifeline Medical, Inc	5438c185-31c9-c51e-e063-6394a90ae9ef	2026-06-14	Warnings	Exact identifier application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 75 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	54106748-9810-d3ff-e063-6394a90a5b7a	2026-06-12	Warnings	Exact identifier application number: M020
Sunbetter Daily Mineral Protection Broad Spectrum SPF 70 Sheer Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	SKINBETTER SCIENCE LLC	5410e0ed-aed5-3279-e063-6294a90a0c3e	2026-06-12	Warnings	Exact identifier application number: M020
Target Up and Up Ultra Light Dry-Touch SPF 70 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	5411f284-f4ed-4e0e-e063-6294a90af1f6	2026-06-12	Warnings	Exact identifier application number: M020
Target Up and Up Oil Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	TARGET CORPORATION	54141120-7682-9c05-e063-6394a90a877e	2026-06-12	Warnings	Exact identifier application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 Sheer	REJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEER	Atlantic Medical Products , LLC	1a2ab632-6443-1aa9-e063-6394a90a0c05	2026-06-11	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 Sunscreen	ENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDE	IT COSMETICS, LLC	f2990320-b61d-40b8-ba79-18d6b37e7f52	2026-06-11	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	6c1c9ae3-650f-4cf6-bf21-d3d5229ec2fa	2026-06-11	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Supra Screen Invisible Sunscreen Serum Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	SICOS ET CIE	3c196ac0-dc07-40ad-865c-8177c75c935a	2026-06-11	Warnings	Exact identifier application number: M020
BelleJoss BROAD SPECTRUM SPF 50	BROAD SPECTRUM SPF 50	Guangzhou Liyan Cosmetics Technology Co., Ltd.	53e1b5ba-45fc-e811-e063-6394a90a65ac	2026-06-10	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