FDA.reportPublic FDA data

Vacation Super

Product NDC
80641-017
11-digit product format
806410017
Labeler code
80641
Product ID
80641-017_137c350b-dca2-47f7-e063-6294a90a531e
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone Homosalate Octisalate Octocrylene
Dosage form
STICK
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-12
Substance
OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
8.6; 2.9; 6.9; 4.9 g/100g; g/100g; g/100g; g/100g
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 Super
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE8.6 g/100g
AVOBENZONE2.9 g/100g
HOMOSALATE6.9 g/100g
OCTISALATE4.9 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
137c350b-dca1-47f7-e063-6294a90a531eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-017-87Vacation Super20 g in 1 APPLICATORSTICK201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-017VACATION SUPER (AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE) STICK [VACATION INC.]1Current NDC, 1 package rows20240314_137c350b-dca1-47f7-e063-6294a90a531e.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 290 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clarity Rx Pucker Power lip plumper SPF 30HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONETopiderm, Inc.92504982-fe0e-404d-b7cf-f6b340b898022024-07-31WarningsExact identifier
application number: M020
Essential Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.2132dc18-85ee-4449-86d2-d9f698f286c62024-07-31WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted foaming mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, Ltd1e78109f-4d2e-2705-e063-6294a90a5ad32024-07-30WarningsExact identifier
application number: M020
Replenix Sheer SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.37d1f454-3bc9-4ce5-863c-0d4f6fa18fb42024-07-29WarningsExact identifier
application number: M020
Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATEDr Pawpaw Limitedf2628e3e-9eb0-49cb-91a6-d15c48cb8a192024-07-25WarningsExact identifier
application number: M020
Thinksport Daily Face SPF 50ZINC OXIDEthinkOperations,LLCb2422785-bd35-4248-a68f-fb4b1492a4cd2024-07-24WarningsExact identifier
application number: M020
Thinkbaby Clear Zinc SPF 30ZINC OXIDEthinkOperations,LLC7cd9c971-5556-42dc-af7b-3a88221b8c942024-07-24WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.0f072099-d57d-4dc4-e063-6394a90ab4382024-07-23WarningsExact identifier
application number: M020
ISNTREE ONION NEWPAIR SUNSCREENAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.14b11b42-d1fe-572f-e063-6394a90a9eec2024-07-23WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1dda8259-4121-3c76-e063-6394a90af1892024-07-22WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.e64c8644-7af4-7b7f-e053-2995a90af7112024-07-22WarningsExact identifier
application number: M020
Thinksport SPF 30ZINC OXIDEthinkOperations,LLC2cecda56-4860-4d35-abc2-2bb9bdf35eae2024-07-19WarningsExact identifier
application number: M020
CVS Health SPORT SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENECVS PHARMACYf0e8c724-b377-5dc0-e053-2995a90a0d542024-07-18WarningsExact identifier
application number: M020
EQUATE Sunscreen SPORT Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INC4d819fd3-de12-4394-82f4-a48faf0b70922024-07-18WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Ultra Sport SunscreenAVOBENZONE HOMOSALATE OCTOCRYLENEBIG LOTS STORES, INC.f0e82a9f-17ac-b1c5-e053-2995a90ae07a2024-07-18WarningsExact identifier
application number: M020
Equaline SPORT Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENEUnited Natural Foods, Inc. dba UNFIf0e8dfd4-a77c-6384-e053-2a95a90a1e4a2024-07-18WarningsExact identifier
application number: M020
TopCare Everyday SPORT Sun Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENETOPCO ASSOCIATES LLCf0e93aa8-1b09-1312-e053-2a95a90a79342024-07-18WarningsExact identifier
application number: M020
Safeway Signature Sport Sunscreen SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENESafeway, Inc.f557a3e2-e415-1b65-e053-2995a90a987a2024-07-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen Sport Broad Spectrum SPF 30AVOBENZONE HOMOSALATE OCTOCRYLENETARGET CORPORATIONbad60bc1-cf78-7a33-e053-2995a90afdc32024-07-18WarningsExact identifier
application number: M020
Scar Gel SPF 35ZINC OXIDEderma e8cd263aa-a54b-4c55-b3e2-6f6763987d4a2024-07-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-017-878064100178720 g in 1 APPLICATOR (80641-017-87) 20 g2024-03-12NoNoCurrent