FDA.reportPublic FDA data

Vacation SPF 30 Mineral

Product NDC
80641-009
11-digit product format
806410009
Labeler code
80641
Product ID
80641-009_29b718d0-b18d-967e-e063-6294a90aa162
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
2023-01-01
Substance
ZINC OXIDE
Active strength
15.5 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
Vacation SPF 30 Mineral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE15.5 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
f69513ae-f210-075f-e053-2a95a90a9b2eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-009-01Vacation SPF 30 Mineral100 mL in 1 TUBELOTION1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-009VACATION SPF 30 MINERAL (ZINC OXIDE) LOTION [VACATION INC.]2Current NDC, 1 package rows20241222_f69513ae-f210-075f-e053-2a95a90a9b2e.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 142 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen Dry Touch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC334ffc49-3196-0995-e063-6394a90ad5592025-12-09Exact identifier
application number: M020
Foam Weightless Sunscreen Non-Tinted Drytouch NTTITANIUM DIOXIDE, ZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC335ec22c-6a9a-c4d1-e063-6394a90ac0b02025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Non-TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3360a208-5f17-a74b-e063-6294a90a13e12025-12-09Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD323356ea-31a0-6ff0-e063-6294a90a135c2025-12-09Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32330376-5db0-202b-e063-6294a90add152025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD32354468-94a2-604b-e063-6394a90adfb52025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD32346536-f542-ef0f-e063-6394a90a04642025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick UntintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD3234b498-5b56-55f4-e063-6294a90a9b872025-12-09Exact identifier
application number: M020
Sunscreen Plus TintedZINC OXIDELily Lee, MD3235a696-92aa-788c-e063-6394a90a01492025-12-09Exact identifier
application number: M020
Sunscreen Plus Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDELily Lee, MD32351db0-884c-8fa0-e063-6294a90acba22025-12-09Exact identifier
application number: M020
Sunscreen Plus UntintedZINC OXIDELily Lee, MD3235786d-7ba9-c9ab-e063-6294a90a7f2e2025-12-09Exact identifier
application number: M020
Tinted Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC31416d04-2d6f-7cf9-e063-6294a90a98062025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral Sunscreen Non-TintedZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143968a-096e-b9ac-e063-6294a90ada0d2025-12-09WarningsExact identifier
application number: M020
Daily Mineral Sunscreen 20% Zinc OxideZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC314299b1-a78b-c1bd-e063-6294a90ab43b2025-12-09WarningsExact identifier
application number: M020
Sheer Satin Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3143d8b0-4af8-f52d-e063-6294a90a926b2025-12-09WarningsExact identifier
application number: M020
Matte Invisible Mineral SunscreenZINC OXIDEINTEGRATIVE AESTHETICS BOSTON, LLC3142ed0f-f379-f240-e063-6294a90a53032025-12-09WarningsExact identifier
application number: M020
Sheer Non-Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33d83cfb-045d-141c-e063-6394a90a2e042025-12-09Exact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Company45875865-5e9c-d652-e063-6394a90ad5fa2025-12-09WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMaloney Plastic Surgery Skin Care, PLLC316b7584-c782-fe9e-e063-6394a90a76fe2025-12-09Exact identifier
application number: M020
Transparent Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEFace Collection, L.L.C.33dbfd9b-b90f-bb32-e063-6294a90af7dc2025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-009-0180641000901100 mL in 1 TUBE (80641-009-01) 100 ml2023-01-01NoNoCurrent