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 31 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunPlus Healthy Skin Sunny Living SPF 30 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC9b168046-3536-4ba9-9b5f-4f8c50b8b3542026-05-14WarningsExact identifier
application number: M020
SunPlus Healthy Skin Sunny Living SPF 50 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC0e60ecee-d9f4-47e0-92f7-ff319e4422dd2026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 15 SunscreenOCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00%S&C Hampton Sun LLC3ce75e74-b5d3-4fbe-8d44-9b6f14f354df2026-05-14WarningsExact identifier
application number: M020
Target Up and Up SPF 30 Deep Repair Facial Moisturizer SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51c9bdee-dcff-2818-e063-6294a90abb472026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 50 Baby MineralZINC OXIDE 20%S&C Hampton Sun LLC42037d8c-4787-4e16-93fe-0d19b6b888fd2026-05-14WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIE29c9d1cb-e249-47fa-a46d-42190e59d3522026-05-14WarningsExact identifier
application number: M020
Hampton SPF 15 UV-Advanced SunscreenHOMOSALATE 7.50% OCTISALATE 5.00% AVOBENZONE 3.00%S&C Hampton Sun LLC1659a681-6cf8-45ba-b1f8-e330eee3b9d42026-05-14WarningsExact identifier
application number: M020
Easy Everything SunscreenZINC OXIDEVLT Ventures LLC51cd48cf-38ae-f347-e063-6294a90a8a902026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 4OCTOCRYLENE 4.00% AVOBENZONE 2.00%S&C Hampton Sun LLC68763abc-0d6b-441c-9a99-cf3dc86e6deb2026-05-14WarningsExact identifier
application number: M020
Easy Everything SunscreenZINC OXIDEVLT Ventures LLC51cdbac3-7f44-d72d-e063-6294a90a2f992026-05-14WarningsExact identifier
application number: M020
Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4feb1010-469f-7e6e-e063-6394a90a9a9e2026-05-14WarningsExact identifier
application number: M020
Round Lab Summer Travel KitAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4f8722e2-4636-e8ba-e063-6294a90a91e42026-05-14WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf3d841aa-b4fe-4a9d-8ad2-edd4445852d22026-05-14WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incb746c24d-f775-4433-8519-49c3ec48ea0c2026-05-14WarningsExact identifier
application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc92a1d6ce-aff3-45fc-8d98-20c4375aded82026-05-14WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATEGuangzhou Haishi Biological Technology Co., Ltd.519d9f52-b704-d6cd-e063-6294a90a6e422026-05-13WarningsExact identifier
application number: M020
Hampton Sun SPF30 MineralZINX OXIDES&C Hampton Sun LLC019b0c1a-f9f3-4756-8b24-35bf4dc4aa222026-05-13WarningsExact identifier
application number: M020
Standard Procedure SPF 50 Sunscreen Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories34f6150d-9627-94a5-e063-6394a90ad4482026-05-13WarningsExact identifier
application number: M020
CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdefa9588-95be-4f5c-86bb-53d6a1df7f5f2026-05-13WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATEGuangzhou Haishi Biological Technology Co., Ltd.22982b28-37df-ed81-e063-6394a90a77db2026-05-12WarningsExact 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