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 92 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	08f4599b-de62-2bc7-e063-6394a90a69ab	2025-12-31	Warnings	Exact identifier application number: M020
Hawaiian Tropic Everyday Active SPF50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc8e2ee8-e67f-ef5d-e053-2995a90a1520	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Glowing, SPF 30	SUNSCREEN GLOWING LOTION	Cardinal Health, Inc	28ed3b60-1139-f657-e063-6394a90a52fa	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Setting Spritz, SPF 45	SUNSCREEN SETTING SPRAY	Cardinal Health, inc.	293e9656-8644-b9aa-e063-6294a90a5b27	2025-12-31	Warnings	Exact identifier application number: M020
Sunscreen Setting Spritz, SPF 45	SUNSCREEN SETTING SPRAY	FSA Store Inc	473d6804-8d20-6899-e063-6294a90a3131	2025-12-31	Warnings	Exact identifier application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47428cd4-fbad-ba7a-e063-6394a90a1c5c	2025-12-31	Warnings	Exact identifier application number: M020
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47433a62-91e0-b031-e063-6294a90a0d49	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4743b6a9-4d79-1b2b-e063-6394a90a9710	2025-12-31	Warnings	Exact identifier application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 Earth	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0edc7bd4-9350-48e1-bbfe-e6450458ae59	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bronze	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	90fbf555-106c-4131-b572-ead9bbb246e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Honey	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1accbe67-c722-4af7-8422-0559ac4a987a	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bare	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5c0805c7-9b92-4c08-877c-64e720308430	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20- Natural	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0cc5429d-ace4-4060-b993-1b607218eaf8	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20-Nude	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	b1851c5d-32ad-482a-bd24-2f280a68ef9e	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 -Spice	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6164dc23-81c2-48b8-b309-2c5a81fe13a4	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4744e501-f12a-6d25-e063-6394a90a2574	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Tawny	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Cappuccino	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	30601a73-089e-4fa7-8fb7-6b108498934a	2025-12-31	Warnings	Exact identifier application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30	ZINC OXIDE SUNSCREEN	SOLARA SUNCARE, INC.	209c4913-29e6-24ca-e063-6294a90a6872	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47456bf5-9f6c-e6a5-e063-6294a90a7054	2025-12-31	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