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 301 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carmex Daily Care Moisturizing Lip Balm SPF 15 Assorted	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	22821e9d-eb3a-4e21-87ae-737b25125534	2024-04-03	Warnings	Exact identifier application number: M020
Meadow and Bark SPF 45 Mineral Shimmer Sunscreen	ZINC OXIDE	Meadow and Bark	14bbd191-ef3b-628e-e063-6294a90a1e66	2024-04-03	Warnings	Exact identifier application number: M020
Meadow and Bark SPF 45 Mineral Sport Sunscreen	ZINC OXIDE	Meadow and Bark	1494c0e1-97f5-411c-e063-6294a90ab2ca	2024-04-03	Warnings	Exact identifier application number: M020
LBEL FOREVER HYDRA BASE HIDRATANTE DE LARGA DURACION FPS 15 HYDRATING LONGWEAR FOUNDATION SPF 15 LATTE 180-F	OCTINOXATE, ZINC OXIDE	BEL STAR S A	ea3a0e07-a277-48c8-e053-2a95a90a172f	2024-04-02	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 BodySpray	OCTOCRYLENE, OCTISALATE, AVOBENZONE	Sol de Janeiro USA, Inc	1520a151-70c4-8699-e063-6294a90adc6b	2024-04-02	Warnings	Exact identifier application number: M020
Meijer SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Meijer	075efd92-1632-d8c8-e063-6294a90a8c1a	2024-04-02	Warnings	Exact identifier application number: M020
Good Molecules Sheer Mineral Sunscreen SPF 30	ZINC OXIDE	Good Molecules, LLC	e9596344-a7ab-f582-e053-2a95a90a5525	2024-04-02	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Carma Laboratories, Inc.	f5c4186e-f167-40fc-b308-0b4406d3ec55	2024-04-02	Warnings	Exact identifier application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF15 Broad Sprectrum Minis Holiday	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carma Laboratories, Inc.	95d9a485-7418-437a-8e7d-ebcc09088356	2024-04-02	Warnings	Exact identifier application number: M020
Rejuvenating Priming Moisturizer BS Sunscreen SPF30	ZINC OXIDE	Allure Labs	14cff1a3-89b9-f4da-e063-6394a90a1a41	2024-03-29	Warnings	Exact identifier application number: M020
Lemongrass Spa Products SPF 45 Tinted Mineral Sunscreen	ZINC OXIDE	Lemongrass Spa Products, LLC	14bcbaf9-76a5-f8ba-e063-6294a90a91f6	2024-03-28	Warnings	Exact identifier application number: M020
Rubber Ducky SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Carefree Skincare Ventures, LLC	14bd5cf9-423e-53a8-e063-6394a90a29f1	2024-03-28	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	132aab60-da19-7079-e063-6394a90a1d76	2024-03-27	Warnings	Exact identifier application number: M020
NAELI TINT Tinted Mineral Moisturizer SPF 50	ZINC OXIDE	ALLI LLC	25a88843-078b-4589-b8b7-ea439ba6a15b	2024-03-27	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 BodyLotion	ZINC OXIDE	SOL DE JANEIRO USA, INC.	14a85a88-c9a2-94ea-e063-6394a90a4e14	2024-03-27	Warnings	Exact identifier application number: M020
Rio Radiance SPF 50 Body Oil	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	SOL DE JANEIRO USA, INC.	14acf152-e72a-debb-e063-6294a90a243d	2024-03-27	Warnings	Exact identifier application number: M020
RV Illuminance Serum Tint Broad Spectrum 15 Amber	FACE FOUNDATION WITH SPF	REVLON CONSUMER PR Consumer Products Corp	2a0ac71c-e53a-5ff9-e063-6394a90a4807	2024-03-27	Warnings	Exact identifier application number: M020
EltaMD UV Pure SPF47	ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	9afe900b-4186-4189-a871-ad6f26fc26e4	2024-03-27	Warnings	Exact identifier application number: M020
Eminence Daily Defense Tinted SPF	ZINC OXIDE	Eminence Organic Skin Care	14854bad-317e-154d-e063-6294a90a884f	2024-03-25	Warnings	Exact identifier application number: M020
SPF 50 Mineral Based Facial Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Hutton, Kathleen MD	5cf0d2e3-d496-424c-ac75-70ff5b87e9ca	2024-03-25	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