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 319 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rosehip and Lemongrass Lip SPF 15ZINC OXIDEEminence Organic Skin Care4354171a-fd25-4c56-a67c-d48194ea98902023-11-30WarningsExact identifier
application number: M020
SOOTHE Daily Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields9acbf663-15e4-4572-a267-56afa58a347b2023-11-30WarningsExact identifier
application number: M020
EltaMD UV Facial SPF30 PlusZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.8426b0a0-ecd6-4486-b2da-57a950b46dc52023-11-30WarningsExact identifier
application number: M020
Eminence Bright Skin Starter Set KitZINC OXIDEEminence Organic Skin Care6335dfaf-ebdf-4b7b-999e-fabeeaa907ed2023-11-29WarningsExact identifier
application number: M020
Cetaphil Healthy Radiance Whipped Day Cream Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.69cdf676-34f6-4864-a2a6-9f547b0b45a02023-11-28WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b24d878-065b-008c-e063-6394a90aa2cf2023-11-27WarningsExact identifier
application number: M020
UNBLEMISH Invisible Matte DefenseHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONERodan & Fields9dfe7d50-f347-4671-9657-5e4fbe42b4412023-11-27WarningsExact identifier
application number: M020
SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aacafca-baf7-9a22-e063-6394a90a2ca92023-11-21WarningsExact identifier
application number: M020
SPF 70 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0aad5ced-f356-e294-e063-6394a90aa8d52023-11-21WarningsExact identifier
application number: M020
SPF 60 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDerma Care Research Labs, LLC0aae69f1-66bf-a199-e063-6394a90a3d752023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0aaeaf00-a438-8164-e063-6394a90a88362023-11-21WarningsExact identifier
application number: M020
Walgreens SPF 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0ab169df-a760-8978-e063-6394a90ac2f42023-11-21WarningsExact identifier
application number: M020
Sun X SPF 50 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMCoreTex Products, INCc0355990-b842-47cd-e053-2a95a90a7c822023-11-20WarningsExact identifier
application number: M020
SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDerma Care Research Labs, LLC0a9b61ac-4f48-8399-e063-6394a90a43fe2023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDERite Aid0a9c1b3f-656d-0d62-e063-6394a90a47312023-11-20WarningsExact identifier
application number: M020
Rite Aid Mineral Zinc Oxide Sunscreen Broad Spectrum SPF 50ZINC OXIDERite Aid0a9c37b1-6df3-37c6-e063-6394a90ac8c32023-11-20WarningsExact identifier
application number: M020
SPF 15 Lip and SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.0b385246-dc77-6874-e063-6394a90a59592023-11-20WarningsExact identifier
application number: M020
Cetaphil Sheer Mineral Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.581e8289-1406-45b6-9786-753800665fad2023-11-20WarningsExact identifier
application number: M020
Alba Botanica Maximum Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Inc02ba8b03-a1fc-608f-e063-6394a90a06a82023-11-16WarningsExact identifier
application number: M020
Alba Botanica Hawaiian SPF 50 CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEHain Celestial Group, Incf693699d-716c-af7f-e053-2a95a90af11a2023-11-16WarningsExact 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