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 169 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Whoa Glow Broad Spectrum SPF 30 Sunscreen Sheer Peach Shimmer SunbeamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.f818f524-0263-4f89-b4f3-4dd83d688e7e2025-11-07WarningsExact identifier
application number: M020
e.l.f Invisible Sunscreen SPF 35AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATEe.l.f. Cosmetics, Incc2af5591-04df-4958-901e-dbe11698b8442025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Blush MuchZINC OXIDEe.l.f. Cosmetics, Inc.53d64042-f9ef-494d-a347-490c6a3c49b82025-11-07WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEe.l.f cosmetics,Inc.547eac8c-492e-4a6b-ac58-4f0d1e0ccb3d2025-11-07WarningsExact identifier
application number: M020
e.l.f Sun Boss Gloss SPF 25 Sunscreen Thats my JamZINC OXIDEe.l.f. Cosmetics, Inc.b7d56015-4734-4ce4-b40d-64236df810e32025-11-07WarningsExact identifier
application number: M020
elf Sun Boss Gloss SPF 25 Sunscreen Peachy KweenZINC OXIDEe.l.f. Cosmetics, Inc.4d9784b6-c54d-483d-a5ba-c557a05300ec2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 ON THE GLOWZINC OXIDEIn The Pynk LLC13badac4-e310-9589-e063-6394a90ab06b2025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 GOLDEN HOURZINC OXIDEIn The Pynk LLC13bb8426-27cd-fbc9-e063-6294a90a8bf82025-11-07WarningsExact identifier
application number: M020
ITP DAILY BAWSE CLEAN, TINTED SUNSCREEN SERUM SPF 28 DEW YOUZINC OXIDEIn The Pynk LLC1365c6d8-64cb-3cb3-e063-6394a90a9d642025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 10wZINC OXIDEe.l.f. Cosmetics, Incc8a935e6-f7ac-4e3a-e053-2a95a90a877a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 11wZINC OXIDEe.l.f. Cosmetics, Incc8a94fb4-8752-587c-e053-2995a90a1e9a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 13wZINC OXIDEe.l.f. Cosmetics, Incc8a9bf6c-80cd-5884-e053-2a95a90a4a662025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 12wZINC OXIDEe.l.f. Cosmetics, Incc8a99278-21e0-c517-e053-2a95a90ade372025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 1CZINC OXIDEe.l.f. Cosmetics, Incc8a82c8b-e308-15e9-e053-2995a90afa2a2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 14wZINC OXIDEe.l.f. Cosmetics, Incc8aa4629-1573-48a7-e053-2995a90aa86c2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 2wZINC OXIDEe.l.f. Cosmetics, Inc.c8a82f54-839d-1de0-e053-2a95a90a2a972025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 4WZINC OXIDEe.l.f. Cosmetics, Incc8a83921-3181-396e-e053-2a95a90a02ee2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 3NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce3e-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 5NZINC OXIDEe.l.f. Cosmetics, Incc8aa6047-ce42-59f7-e053-2a95a90a678e2025-11-07WarningsExact identifier
application number: M020
Well People Bio Tint SPF 30 Sunscreen 6wZINC OXIDEe.l.f. Cosmetics, Incc8a8ef6f-4426-a981-e053-2a95a90a94512025-11-07WarningsExact 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