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 340 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
REPAIRWEAR LASER FOCUS LINE SMOOTHING BROAD SPECTRUM SPF 15 -VERY DRY TO DRY COMBINATION	OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	4c40047b-01d6-4221-a044-9f884519bdd5	2023-10-05	Warnings	Exact identifier application number: M020
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - COMBINATION/OILY TO OILY	AVOBENZONE AND OCTISALATE	CLINIQUE LABORATORIES LLC	9c9a0fa4-b440-4d7f-805e-d997e120024d	2023-10-05	Warnings	Exact identifier application number: M020
EVEN BETTER GLOW LIGHT REFLECTING MAKEUP BROAD SPECTRUM SPF 15	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	756cb656-2f79-4e7f-b4b3-18d6e8930921	2023-10-05	Warnings	Exact identifier application number: M020
bareMinerals ORIGINAL Liquid Mineral Foundation Broad Spectrum SPF 20 Sunscreen FAIR 01	TITANIUM DIOXIDE	Orveon Global US, LLC	f083af9e-e235-5f03-e053-2a95a90a5325	2023-10-04	Warnings	Exact identifier application number: M020
Fair Foundation SPF 15	ZINC OXIDE, TITANIUM DIOXIDE	Orveon Global US, LLC	491a5768-1aad-458e-b4d6-72ea085d1d9f	2023-10-04	Warnings	Exact identifier application number: M020
BAREMINERALS SPF 20 CORRECTING CONCEALER Dark 2	TITANIUM DIOXIDE	Orveon Global US LLC	6845acee-5a3f-4c8d-9386-8823b30373f3	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01	TITANIUM DIOXIDE	Orveon Global US, LLC	798934af-f011-4a95-bdb6-b577154713c4	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Brightening Concealer SPF 25 Deep Mahogany	TITANIUM DIOXIDE	Orveon Global US LLC	f03b4fa3-4da9-5e44-e053-2a95a90af344	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Tinted Hydrating Broad Spectrum SPF 30 Cashew 3.5	TITANIUM DIOXIDE	Orveon Global US LLC	2de76f3c-b438-47ca-84e5-e871e9d995a4	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fair Ivory	TITANIUM DIOXIDE	Orveon Global US LLC	15c92bce-75f4-40e3-ae28-9bcbc241c8e9	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Complexion Rescue Defense Radiant Protective Veil Broad Spectrum SPF 30 Soft Radiance	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	0c2db44d-8604-4883-ab01-f14bc441e4e4	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Beige 12	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3c35fd13-1a4b-4acf-ada4-16ee2e52dd94	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Prime Time BB Primer-Cream Broad Spectrum SPF 30 Medium	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	3cc5b952-4619-4395-97c0-5b68efa9af6d	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Skinlongevity Vital Power Moisturizer Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	29c25bc3-902a-41af-996a-8c7e8a4bf574	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Light 03	TITANIUM DIOXIDE	Orveon Global US LLC	b2909888-5a98-4894-a895-230aa53f64d9	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Tan 19	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	a5888955-f381-4209-9589-bd2e79a84f59	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	ad15bdee-67e6-4281-8144-e84b7c478a34	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Tan 18	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	aa4d7945-6cc9-4f20-b588-a5588e57d30a	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Tan 20	TITANIUM DIOXIDE AND ZINC OXIDE	Orveon Global US LLC	2f8b6c57-dcae-408e-898d-d5630deeb090	2023-10-04	Warnings	Exact identifier application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Neutral Dark 24	ZINC OXIDE	Orveon Global US LLC	beaf1ff7-4942-4ba5-ba25-3287cc409e93	2023-10-04	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