FDA.reportPublic FDA data

Vacation Lip Balm

Product NDC
80641-520
11-digit product format
806410520
Labeler code
80641
Product ID
80641-520_7d6947d5-8d03-4bf2-8ca7-0847efa7c0cc
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
GEL
Route
TOPICAL
Labeler
Vacation INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 3; 4; 10 g/100mL; g/100mL; g/100mL; g/100mL
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 Lip Balm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE3 g/100mL
OCTISALATE4 g/100mL
OCTOCRYLENE10 g/100mL

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
b442530f-cae3-418b-9675-c18879653826Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-520-01Vacation Lip Balm15 mL in 1 TUBEGEL151

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 startSampleExclude flagStatus
80641-520-018064105200115 mL in 1 TUBE (80641-520-01) 15 ml2026-01-01NoNoCurrent