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 317 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Slip Tint Broad Spectrum SPF 35 Tinted Moisturizer	ZINC OXIDE	Clean Beauty For All, Inc	ccf9daf4-0bf0-2610-e053-2a95a90a3f07	2023-12-12	Warnings	Exact identifier application number: M020
MINERAL BODY SUNSCREEN UNSCENTED	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	17cb6a73-5bfe-4227-ab9f-f6dd90bac266	2023-12-12	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight	TITANIUM DIOXIDE	LOreal USA Products Inc	4692b146-1abe-48e8-b097-ea9c556962b6	2023-12-11	Warnings	Exact identifier application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Phyto Peptides Vitamin C	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	40fd5146-f4f0-4c2d-a786-d18f8ade1bef	2023-12-11	Warnings	Exact identifier application number: M020
Vichy Laboratories LiftActiv Peptide-C SPF 30 Sunscreen Phyto Peptides Vitamin C	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	Cosmetique Active Products	f5b3e52e-64f7-4e97-ba74-60de904b8771	2023-12-11	Warnings	Exact identifier application number: M020
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	acb887bc-7e46-4257-9fe3-a2cade6c4f38	2023-12-11	Warnings	Exact identifier application number: M020
Solar Defense Body	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	HydroPeptide LLC	45ec77c5-5eb3-0e51-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier application number: M020
Erborian BB creme au Ginseng chocolate SPF 20	OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ddcd6ea4-e7b1-88df-e053-2a95a90a9923	2023-12-09	Warnings	Exact identifier application number: M020
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	43c81760-6bb6-25fe-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier application number: M020
Erborian CC Dull Correct SPF25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	cb23ba95-1e83-4523-a35c-3b70c0605dd1	2023-12-09	Warnings	Exact identifier application number: M020
Carmex Classic Lip Balm Medicated Free Wintergreen Stick	OCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	bc0162bc-92ca-ee78-e053-2a95a90a7c9d	2023-12-08	Warnings	Exact identifier application number: M020
Raw Elements Eco Formula SPF30 Sample Packs	ZINC OXIDE	Raw Elements LLC	9e91e228-0b5e-4577-9d57-cdb9e9a705e8	2023-12-08	Warnings	Exact identifier application number: M020
Multi-Active Jour SPF 20 Broad Spectrum Sunscreen	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Laboratoires Clarins	432f07e8-6f0f-4946-b1b6-4559ef1af561	2023-12-08	Warnings	Exact identifier application number: M020
CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Laboratoires Clarins	ae34fdcb-d372-435f-bf7c-075ea554b2fe	2023-12-08	Warnings	Exact identifier application number: M020
UV ESSENTIEL COMPLETE UV PROTECTION SUNSCREEN ANTIOXIDANT ANTI-POLLUTION BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	CHANEL PARFUMS BEAUTE	df2a43b4-eab9-48cd-a4b6-d00cfc925477	2023-12-08	Warnings	Exact identifier application number: M020
SERIOUS SKINCARE SERIOUS-C3 PLASMA TM BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30	AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONE	Flageoli Limited	4833b0b1-33b7-59d4-e054-00144ff8d46c	2023-12-07	Warnings	Exact identifier application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier application number: M020
CLARINS BROAD SPECTRUM SPF 50 Sunscreen Body	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE,	Laboratoires Clarins	7feb0679-6557-4917-a386-7ce2c14a94e2	2023-12-06	Warnings	Exact identifier application number: M020
CLARINS BROAD SPECTRUM SPF 50 Dry Touch Facial Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE	Laboratoires Clarins	5bddb1d6-2493-41bf-8c14-73f103c55aa7	2023-12-05	Warnings	Exact identifier application number: M020
Sea Clearly Hydrating Facial SPF 35 Kinetin	OCTOCRYLENE, OCTISALATE,HOMOSALAT, AVOBENZONE	Allure Labs	0bc829ff-34a0-03e9-e063-6294a90a10ae	2023-12-05	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