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 73 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FourZINC OXIDEClean Beauty For All, Inc (dba Saie)1922e001-e699-7ac5-e063-6394a90a25d92026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SixZINC OXIDEClean Beauty For All, Inc (dba Saie)a9350360-7932-459f-806c-399fa265e6c02026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade ThreeZINC OXIDEClean Beauty For All, Inc (dba Saie)1923067f-1ab9-d168-e063-6394a90adbd02026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Five and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922ee84-d7d0-80b1-e063-6394a90acf7b2026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade SevenZINC OXIDEClean Beauty For All, Inc (dba Saie)310a07bb-d32a-401f-955e-4c2860148a302026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade FiveZINC OXIDEClean Beauty For All, Inc (dba Saie)39ae4a97-7f96-4c95-a6de-0c779764fb022026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade Four and HalfZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc3e-055c-e51d-e063-6294a90a00f52026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade NineZINC OXIDEClean Beauty For All, Inc (dba Saie)9c7a31df-5bdd-403b-b807-1d1a801e1bb62026-01-20WarningsExact identifier
application number: M020
Slip Tint Broad Spectrum SPF 35 Sunscreen Tinted Moisturizer Shade OneZINC OXIDEClean Beauty For All, Inc (dba Saie)1922fc51-ae53-acb8-e063-6394a90a14eb2026-01-20WarningsExact identifier
application number: M020
Wrinkle Repair Moisturizer SPF 30 EQBAVOBENZONE 2% HOMOSALATE 4% OCTISALATE 4% OCTOCRYLENE 2%Walmarta067e968-e598-40ef-95f2-c338b5e413dd2026-01-20WarningsExact identifier
application number: M020
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
application number: M020
SPF 50 Mineral Sunscreen KidsZINC OXIDE 14.69%S&C Hampton Sun LLC0bdb7d15-dc52-4e23-9417-fe73f17f61102026-01-20WarningsExact identifier
application number: M020
DEWYTREE URBAN SHADE INVISIBLE SMOOTHING PORE SUNSTIC SUNSTICKOCTOCRYLENE, HOMOSALATE, ZINC OXIDE, OCTISALATEDEWYTREE CO. ,LTD48406e68-eefd-d2c2-e063-6394a90a4ad92026-01-20WarningsExact identifier
application number: M020
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
application number: M020
CHUDAAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATEPremier Ocher LLC1bc2a2df-a4cd-45e7-93c6-b35dbd8b280f2026-01-20WarningsExact identifier
application number: M020
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
application number: M020
PROJECT REEF SPF-30 Mineral SunscreenZINC OXIDEProject Reef LLCa6077e6f-d987-4159-946f-3e23972476592026-01-19WarningsExact identifier
application number: M020
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
application number: M020
SABAL Mineral Sunscreen Broad Sprectrum SPF 30ZINC OXIDESABAL SUN LLCf917b446-4e10-4231-826e-fdac32e111862026-01-19WarningsExact identifier
application number: M020
Plius Daily SPF Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEPLIUS, Inc31866de9-afa0-4c11-be65-b613735514932026-01-19WarningsExact 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