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 91 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact identifier
application number: M020
Bellas Friends Sunscreen StickZINC OXIDEPanergytek Usa Inc478cbdeb-28e4-fa56-e063-6294a90af1242026-01-04WarningsExact identifier
application number: M020
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Clear SunshineZINC OXIDECyberderm Laboratories inc.a8646ee4-5e6e-6cdd-e053-2a95a90aee772026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Strawberry ZinniaZINC OXIDECyberderm Laboratories inc.a888396f-489f-7e7c-e053-2995a90aee5b2026-01-01WarningsExact identifier
application number: M020
Ava Isa Sun Lip Sun Whip Watermelon LilyZINC OXIDECyberderm Laboratories inc.a8889754-8e33-4d2a-e053-2995a90a60802026-01-01WarningsExact identifier
application number: M020
OKeeffes Lip RepairAVOBENZONE, DIMETHICONE, OCTINOXATE, OCTOCRYLENEThe Gorilla Glue Company/O'Keeffe's Company6805b3e9-77cb-bfee-e053-2991aa0a8d982026-01-01WarningsExact identifier
application number: M020
Walgreens 50 Pina Colada Scented SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY4978c811-be34-9fc3-e063-6394a90a2d802026-01-01WarningsExact identifier
application number: M020
Unicorn Snot 35 SPF Glitter Spritz rose gold shimmerAVOBENZONE, OCTISALATE, OCTOCRYLENEJailbreak Toys, Inc. DBA UNICORN SNOT498b7c1a-e66d-9736-e063-6394a90a47122026-01-01WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBCM Ltdf7d5aa8a-9f4a-426b-ac9d-9690cf0103e02026-01-01WarningsExact identifier
application number: M020
MAUI ISLAND SECRET BROWNING CREME Broad Spectrum Sunscreen SPF 5ZINC OXIDEFormula 7venz L.L.C.5f3cdec9-2cc2-4660-827f-d286883d907c2025-12-31WarningsExact identifier
application number: M020
SOLARA SUNCARE - GO VACATION GLOW SPF 30ZINC OXIDESOLARA SUNCARE, INC.1f5cb694-f065-7ebc-e063-6394a90a883a2025-12-31WarningsExact identifier
application number: M020
SUNSCREEN GLOWING, SPF 30SUNSCREEN GLOWING LOTIONFSA Store Inc473bcb90-ab7f-170b-e063-6294a90a99d52025-12-31WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC05ba5966-f0ff-5360-e063-6294a90a0fc92025-12-31WarningsExact 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