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 294 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEBiocosmetica Exel Argentina SRLb2965aba-fcde-16f6-e053-2995a90aa9d82024-06-30WarningsExact identifier
application number: M020
Sun Shield On-the-Glow Sheer Stick SPF40AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c237d5a-1663-e9a1-e063-6294a90a6a242024-06-30WarningsExact identifier
application number: M020
Exel Clarifying Line SPF 50OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDEExelencia importers0d6d4098-4121-477e-b404-3ab18628ed682024-06-30WarningsExact identifier
application number: M020
Silk Line Silk Day Cream SPF 15OCTINOXATE, OCTOCRYLENE, OCTISALATEExelencia Importers, Corp.b2d35086-748b-55d0-e053-2995a90a18982024-06-30WarningsExact identifier
application number: M020
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc28c51c59-dbfb-45e5-b536-6e5d5c5560d62024-06-28WarningsExact identifier
application number: M020
Sun Shield Body Glow SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEKoco Life LLC180aa4d5-6dac-e658-e063-6394a90a32872024-06-28WarningsExact identifier
application number: M020
Rose Gold Sun Shield Body Glow SPF45AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1bf7d147-7051-2e76-e063-6294a90a1d132024-06-28WarningsExact identifier
application number: M020
Golden Amber Sun Shield Body Glow SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC1bf97569-024a-9ef1-e063-6394a90a28222024-06-28WarningsExact identifier
application number: M020
Jergens Natural Glow Face Daily Moisturizer for Fair/Medium SkinAVOBENZONE, OCTISALATE, OCTOCRYLENEKao USA Inc.365a98e0-737b-12b3-e054-00144ff8d46c2024-06-28WarningsExact identifier
application number: M020
Antioxidant Face Shield Mineral SPF30ZINC OXIDEKoco Life LLC1c31a971-0402-e12a-e063-6294a90ac91d2024-06-28WarningsExact identifier
application number: M020
Sun Essentials SPF Duo KitAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEKoco Life LLC1c329b86-664e-de1f-e063-6394a90a7c232024-06-28WarningsExact identifier
application number: M020
IT COSMETICS YOUR SKIN BUT BETTER CC PLUS NUDE GLOW Color Correcting Medium Coverage Skin Tint plus Brightening Glow Serum plus Broad Spectrum SPF 40 SunscreenHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Ince879c055-9611-46a2-bcf6-8dd0a29a31292024-06-28WarningsExact identifier
application number: M020
Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry SkinOCTINOXATEL'Oreal USA Products Inc90326e7e-8fdf-4221-afc0-208774d8ba6f2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Collagen Moisture Filler Ultra Light Moisturizing Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incc21fdc5e-236a-4a8e-ad59-1d9cd75074242024-06-28WarningsExact identifier
application number: M020
Kiehls Ultra Facial Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6925c546-056e-4be8-b4e9-55da0b6b62b32024-06-28WarningsExact identifier
application number: M020
LOreal Paris Age Perfect Radiant Foundation Broad Spectrum SPF 50 Sunscreen with Antioxidants plus Concentrated SerumHOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc799c547c-a17a-43ee-92fc-061b5ec8a40c2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incf6457973-3718-44cd-a764-de0b089d4eee2024-06-28WarningsExact identifier
application number: M020
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc8598d56b-adcd-48e8-b6fc-77bc934009c72024-06-27WarningsExact identifier
application number: M020
MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5OCTINOXATEL'Oreal USA Products Inc12ec5a93-8c24-4ac9-94df-910dd8137e002024-06-27WarningsExact identifier
application number: M020
Kiehls Since 1851 Dermatologist Solutions AutoTone Discoloration and UV Solution Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6dbbc8ce-9457-4405-bb38-aa0c7550c62c2024-06-27WarningsExact 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