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 18 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC365613b6-36ec-0512-e063-6294a90a95322026-06-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC235a9430-b445-8d5c-e063-6394a90a93542026-06-24WarningsExact identifier
application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Broad Spectrum SPF 100 Body and Face Melt In Milk Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc511f6de9-264a-4cf2-97c3-aa8adbc52a872026-06-23WarningsExact identifier
application number: M020
fmg Cashmere Lip Glaze Broad Spectrum SPF 30 SunscreenZINC OXIDETHE AVON COMPANY54f1b153-c79b-bcf8-e063-6394a90ae4262026-06-23WarningsExact identifier
application number: M020
CVS 70 Daily Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY54f25934-b4c4-4fc8-e063-6294a90a543a2026-06-23WarningsExact identifier
application number: M020
Soleil Set sunscreen SPF 50AVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%The Soleil Groupcc4e4b99-5f42-4a93-a3a0-ea19f57d27832026-06-23WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE AVON COMPANY54f6d7c1-59d1-0b36-e063-6394a90a17a32026-06-23WarningsExact identifier
application number: M020
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
application number: M020
Babo Botanicals Daily Dew Milk Mineral Sunscreen SPF 27ZINC OXIDEBabo Botanicals, Inc.54db8d28-2bb5-3ae4-e063-6294a90aa5ad2026-06-22WarningsExact identifier
application number: M020
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
application number: M020
Mama and Hapa s - Bulk Sunscreen Extra SensitiveZINC OXIDE SUNSCREENVEGANIC SKN LIMITED54e18569-2e51-366a-e063-6394a90af8ec2026-06-22WarningsExact identifier
application number: M020
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
application number: M020
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 SUNCARE COCO LOCOBy the Beach Suncare LLC549be1ca-df21-a643-e063-6394a90ac0262026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL COCO LOCOBy the Beach Suncare LLC549bad35-3005-875b-e063-6394a90ad31e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL MELON DAZEBy the Beach Suncare LLC549bbd19-8e22-e420-e063-6294a90a6a982026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CANDY CLOUDSBy the Beach Suncare LLC549bd1b1-a6e2-b35c-e063-6394a90a8d0e2026-06-19WarningsExact identifier
application number: M020
By the Beach SuncareSPF 30 FACE AND BODY DRY OIL CITRUS CRUSHBy the Beach Suncare LLC549bd1b1-a6ee-b35c-e063-6394a90a8d0e2026-06-19WarningsExact 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