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
IngredientStrength
ZINC OXIDE20.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
131b7e65-7155-f925-e063-6394a90a1d7aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-014-60Mineral Shake15 mL in 1 BOTTLELOTION153
80641-014-75Mineral Shake50 mL in 1 BOTTLELOTION503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-014MINERAL SHAKE (ZINC OXIDE) LOTION [VACATION INC.]3Current NDC, 2 package rows20240315_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 154 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CANNON BALM 140AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEDUKE CANNON SUPPLY CO.f70c8632-ed11-0cc3-e053-6394a90a77db2025-12-03WarningsExact identifier
application number: M020
Omega-Boost Sheer Mineral SunscreenMINERAL SUNSCREENTrilogy Natural Products Limited0405b7a6-6885-ed93-e063-6294a90a93862025-12-03WarningsExact identifier
application number: M020
Poolside Hot Head SPF 30 hair scalp sunscreen mistHOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517da75-c91a-1f93-e063-6394a90a65ac2025-12-03WarningsExact identifier
application number: M020
Poolside Tropic Touch SPF 30 Sunscreen Body spray.HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONELongway Technology(Guangzhou)Co.,Ltd.4517ef95-8ea1-3de6-e063-6394a90a2c792025-12-03WarningsExact identifier
application number: M020
Poolside Orange Creme SPF 30 Sunscreen oil mistHOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3%Longway Technology(Guangzhou)Co.,Ltd.4517fd05-ea60-0492-e063-6294a90a28e92025-12-03WarningsExact identifier
application number: M020
e.l.f. All Set For Sun SPF 45 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.26f43446-e5ee-57a5-e063-6394a90a86612025-12-03WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC7678467a-9da3-1b51-e053-2991aa0a568f2025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECARDINAL HEALTH, INC.b60cf360-7c8d-5da4-e053-2995a90a24c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b6107d22-a992-eaa1-e053-2995a90a29c22025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader General Protection Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b623defb-4a9d-6fc5-e053-2995a90ae8462025-12-02WarningsExact identifier
application number: M020
Cardinal Health Leader Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.b62329d7-29e9-d111-e053-2a95a90aab062025-12-02WarningsExact identifier
application number: M020
Leader Ultra Sheer SPF 100 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONECARDINAL HEALTH, INC.b5a467e0-a6ab-4136-8101-f22cc319de582025-12-02WarningsExact identifier
application number: M020
Leader General Protection SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH, INC.9544b046-055e-5886-e053-2a95a90ad09e2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44fe0844-cb74-7a04-e063-6294a90aca152025-12-02WarningsExact identifier
application number: M020
CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC44fe7468-001c-f2ee-e063-6394a90ae3b42025-12-02WarningsExact identifier
application number: M020
ATTITUDE Super Leaves Lip Balm SPF15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff1fc0-9ac5-2c9a-e063-6294a90a46322025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 CoconutZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ff5675-fd8d-b665-e063-6294a90a1e0b2025-12-02WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 PineappleZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ffb35b-80f4-7ddb-e063-6394a90a2cbb2025-12-02WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC44ffd469-0205-846f-e063-6294a90af6b52025-12-02WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.daf0291e-770c-eaf2-e053-2a95a90a0b672025-12-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-014-608064100146015 mL in 1 BOTTLE (80641-014-60) 15 ml2024-03-07NoNoCurrent
80641-014-758064100147550 mL in 1 BOTTLE (80641-014-75) 50 ml2024-03-07NoNoCurrent