FDA.reportPublic FDA data

VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

Product NDC
80641-001
11-digit product format
806410001
Labeler code
80641
Product ID
80641-001_47224083-a029-4253-9660-b228c66263ff
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-15
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
25; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE25 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c7794831-52d1-4d80-936d-44af18ae0472Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80641-001-012024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-022024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-032024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-012024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-022024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-032024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-001-01VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN100 mL in 1 TUBELOTION1008
80641-001-02VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN30 mL in 1 TUBELOTION308
80641-001-03VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN7 mL in 1 PACKETLOTION78
80641-001-04VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN177 mL in 1 TUBELOTION1778
80641-001-04VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN2 in 1 KITLOTION28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-001VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [VACATION INC.]5Current NDC, Legacy NDC, 5 package rows20250109_c7794831-52d1-4d80-936d-44af18ae0472.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 311 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LOreal Paris Youth Code Dark Spot Corrector Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inca32f7458-d7ad-47e5-804d-de260c0726de2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Infallible Up to 24 H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc917f6775-8f48-4b7e-9f67-253bc0c6d59e2023-12-29WarningsExact identifier
application number: M020
LOreal Paris Revitalift Triple Power Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc9b6adfab-cafa-4343-9c96-e187fe0986db2023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - STRAWBERRY SUNBURSTZINC OXIDE SUNSCREENBentley Laboratories, LLC4785585e-b623-4125-9867-8097694c7b582023-12-29WarningsExact identifier
application number: M020
LOreal Paris Visible lift Serum Absolute Advanced Age Reversing Makeup Broad Spectrum SPF 17OCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inca31dacaa-738d-4da8-95b2-4d737c5266832023-12-29WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Cell Renewal Day Moisturizer Broad Spectrum SPF 25 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc8e294a61-97e2-4df8-8a59-7cec12c6f0162023-12-29WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30- SUNSET ROSEZINC OXIDE SUNSCREENBentley Laboratories, LLCe351dff2-4237-4458-a947-b894e7b670a32023-12-29WarningsExact identifier
application number: M020
LOreal Paris Wrinkle Expert Age Defense 55 Plus Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incfa0b25a9-648a-4c7e-95c0-b7cb3dd525dd2023-12-29WarningsExact identifier
application number: M020
Radiant Shield Broad spectrum SPF 40 Tinted Mineral SunscreenZINC OXIDECosMedical Technologies, LLCef75cd9d-eaf5-430e-9a80-30c50da921ff2023-12-28WarningsExact identifier
application number: M020
SkinCeuticals Daily Brightening UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc76e03a17-947a-492a-9e64-d3f7762de8232023-12-28WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios UV Hydra Daily Invisible Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inccc61299b-5088-4cef-b90e-f5de67e46b252023-12-28WarningsExact identifier
application number: M020
Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incea0609be-eaa9-4b63-9f07-e2cd974e01ba2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incb3a37055-b58f-4c42-963b-01c1136f692d2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Me Foundation Dewy Plus Smooth SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Inc52e169b7-3560-489e-b7ab-1fea01466c0c2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Fit Me Matte Plus Poreless Mattifying Poreless Primer Broad Spectrum SPF 20 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Incc0c2aac2-1cd3-4e97-894c-a828fd9dba9b2023-12-28WarningsExact identifier
application number: M020
Maybelline New York Master Prime By Face Studio Primer Broad Spectrum SPF 30 SunscreenOCTINOXATELOreal USA Products Incfeabb713-4ef1-45b3-b34f-562e37b314d52023-12-28WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETekweld Solutions, Inc.dc3f8339-23c1-4882-8682-685623027bdf2023-12-27WarningsExact identifier
application number: M020
Dermablend Professional Smooth Camo Medium Coverage Foundation Broad Spectrum SPF 25 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incaec1957a-f68d-4fbd-af9e-f8b257daea462023-12-27WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 60 Daily AntiAging Face and Body Sunscreen Broad Spectrum SPF 60 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc8404ef40-35fd-4460-a35f-d473b3c04c872023-12-27WarningsExact identifier
application number: M020
Dermablend Professional CC Continuous Correction Full Coverage Makeup Broad Spectrum SPF 50 Plus SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc4514240-f09b-48e3-94d6-d45dc426900e2023-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80641-001-0180641000101100 mL in 1 TUBE (80641-001-01) 100 ml2022-04-060000-00-00NoNoCurrent
80641-001-028064100010230 mL in 1 TUBE (80641-001-02) 30 ml2022-04-060000-00-00NoNoCurrent
80641-001-03806410001037 mL in 1 PACKET (80641-001-03) 7 ml2022-04-060000-00-00NoNoCurrent
80641-001-04806410001042 TUBE in 1 KIT (80641-001-04) / 177 mL in 1 TUBE2 tube2024-03-01NoNoCurrent