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 66 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zealios Mineral SPF 30 SunscreenZINC OXIDEPersonal Best Products Inc. dba Zealiosc421b00c-6536-4455-81f6-01686f8c23882026-02-03WarningsExact identifier
application number: M020
Zealios Sport Performance Ultralight SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEPersonal Best Products Inc. dba Zealios020bd1b4-da50-4117-a4f3-b74aa41873962026-02-03WarningsExact identifier
application number: M020
Adrien Arpel Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Incf65e1428-b79a-4126-862a-907ca17ee8f72026-02-02WarningsExact identifier
application number: M020
Flori Roberts Daily Defense Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEColor Me Beautiful Inc934d6b80-0cc3-4dcd-a25d-2191bd2736182026-02-02WarningsExact identifier
application number: M020
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
application number: M020
HAMPTON SUN SPF50 SUNSHIELD BODY GLOWHOMOSALATE 10% OCTOCRYLENE 10% AVOBENZONE 3% OCTICALATE 5%S&C Hampton Sun LLC26190992-9463-47ae-86a5-0dbc05be87732026-02-02WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENERite Aid Corporationfe9146ec-b85d-43da-a391-377960f2c7722026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
sheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation299a6690-9746-4410-a625-7636f0b4a7542026-02-02Warnings, Adverse reactionsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENEFarmasi US LLC49dc6040-b400-7f5b-e063-6394a90ac7d72026-02-02WarningsExact identifier
application number: M020
Naturium Dew Glow Moisturizer Mineral SPF 50ZINC OXIDEe.l.f. Cosmetics, Inc535f798f-d21d-92b2-e063-6294a90a72c72026-02-02WarningsExact identifier
application number: M020
Sol de Janiero Rio Radiance SPF 50 BodyZINC OXIDECosmetic Solutions LLC2d54727d-5dcc-4792-85e8-1a2f21fe9e3d2026-02-02WarningsExact identifier
application number: M020
Sky and Sol Face and Body Sunscreen Spf 50ZINC OXIDEDelta Ecommerce LLC47d9dc66-328f-4cab-e063-6394a90a279d2026-02-01WarningsExact identifier
application number: M020
e.l.f. Suntouchable Invisi-Stick Glitz SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f cosmetics,Inc.4b801bb3-8930-7e04-e063-6294a90adaa12026-02-01WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR CLEARAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationcedd7a3e-3334-437f-a283-482bcd0064ee2026-01-30WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationbf16e8b5-b717-4255-a7da-9abe3d1ad8b42026-01-30WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERite Aid Corporation372a8fba-b190-40fe-a1fc-fecf7f7afc352026-01-30Warnings, Adverse reactionsExact identifier
application number: M020
ALOE UP MEDICATED LIP BALM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEAloe Care International, LLC859b6d3f-b1ca-4966-8f0c-f9afa0d5864c2026-01-30WarningsExact identifier
application number: M020
ALOE UP SPORT NATURAL BALM SPF-15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEAloe Care International, LLC3de029ed-97f7-4cb3-a32e-d412bf3b58742026-01-30WarningsExact identifier
application number: M020
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
application number: M020
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact 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