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 235 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Meet Your Flawless Matte Skin DuoOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDESocoplan3541c41b-f114-4734-a66f-be309ca6f3bf2025-01-16WarningsExact identifier
application number: M020
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
application number: M020
Snap On Racing Sunscreen KitAVOBENZONE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEGreater Pacific Industries, Inc.9f4f91d0-0fc5-43a3-be79-afce5afa2f952025-01-16WarningsExact identifier
application number: M020
Emme Diane Pure Protection Tinted Antioxidant SunscreenZINC OXIDEEmme Diane, Inc.b2b4daf5-765b-426d-8a72-9278f7cd43d72025-01-16WarningsExact identifier
application number: M020
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
application number: M020
Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40ZINC OXIDESUNNY SAILOR LLC14ea2d11-c425-45d8-a23a-d4ed82a6439c2025-01-15WarningsExact identifier
application number: M020
glo SKIN BEAUTY Oil-Free Tinted Primer SPF 30GLO SKIN BEAUTY OIL-FREE TINTED PRIMER SPF 30Hayden Caleel LLC00bf7331-c9dc-4a8a-9ff3-901e0d07eac62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc42f6f-4eaf-fa28-e063-6294a90a93fb2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 Broad SpectrumHOMOSALATE, OCTOCRYLENE, OCTISALATE, ZINC OXIDEBlack Girl Sunscreen, LLC2bc419b3-4de2-7ed9-e063-6394a90a255f2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc47bd0-d81b-f1b9-e063-6394a90ad3752025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50OCTOCRYLENE, OCTISALATE, HOMOSALATE, AVOBENZONEBlack Girl Sunscreen, LLC2bc46854-fe67-782b-e063-6294a90a79af2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 50 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATEBlack Girl Sunscreen, LLC2bc471f0-c93e-0c51-e063-6394a90a77f02025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4b1b1-5f19-7ba3-e063-6394a90a5de72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4c639-787a-d2d3-e063-6394a90a5ded2025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4d937-77d0-273c-e063-6394a90a25e72025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4cfd9-e44c-9b93-e063-6394a90a96a62025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4e22d-6265-9c0b-e063-6394a90a15412025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc4eb32-8c0b-32fc-e063-6294a90a16252025-01-15WarningsExact identifier
application number: M020
Black Girl Sunscreen Sunscreen SPF 30 broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBlack Girl Sunscreen, LLC2bc50182-30f2-b77e-e063-6394a90a63552025-01-15WarningsExact 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