FDA.reportPublic FDA data

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 116 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
application number: M020
Replenishing Daily SunscreenZINC OXIDEBABYFACE LLC36d773d7-349d-68c1-e063-6394a90aff1e2025-12-16Exact identifier
application number: M020
TiZO Tinted Moisturizing Serum - LightZINC OXIDEFallien Cosmeceuticals, Ltd.2d44158a-44b3-5a3d-e063-6294a90a1f162025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Light-MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d53071f-0275-d00c-e063-6294a90afcca2025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - MediumZINC OXIDEFallien Cosmeceuticals, Ltd.2d550967-25af-3e7a-e063-6394a90a2c792025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - Medium-DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d57790c-22cf-08aa-e063-6394a90aeac02025-12-16WarningsExact identifier
application number: M020
TiZO Tinted Moisturizing Serum - DeepZINC OXIDEFallien Cosmeceuticals, Ltd.2d5813e8-a219-db90-e063-6294a90a6ca72025-12-16WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
application number: M020
Daily Protect Mineral SunscreenZINC OXIDESARAH'S4617beb7-381e-8994-e063-6394a90a14b52025-12-16WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENTENSULIZOLE, HOMOSALATE, OCTISALATE, ZINC OXIDEShiseido Americas Corporation8db9f5e0-a8d6-4872-b4c6-cb92c43d25c22025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation18ed9b7f-bdbe-45d7-a38c-6d065080ae992025-12-16WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE FOR BODY NENSULIZOLE, OCTISALATE, OCTOCRYLENE, ZINC OXIDEShiseido Americas Corporationa2bbf6f8-b8ad-4cd9-abeb-7ec0a4ddb45c2025-12-16WarningsExact identifier
application number: M020
b.tan Beach Please SPF 7AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarque of Brands Americas, LLCbdc07d83-a34f-5262-e053-2995a90acfc32025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S461910bd-1f74-f99e-e063-6394a90ae30e2025-12-16WarningsExact identifier
application number: M020
Daily Protect Tinted Mineral SunscreenZINC OXIDESARAH'S4619b08f-3e63-25aa-e063-6294a90a78d72025-12-16WarningsExact identifier
application number: M020
megALL DAY SOOTHE SUN SHIELD BROAD SPECTRUM SPF48Meg Cosmetics Inc4526bacf-6451-b297-e063-6294a90af71a2025-12-16WarningsExact 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