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 127 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36af24e2-015a-a9a7-e063-6294a90a2fce2025-12-15Exact identifier
application number: M020
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEBASS & KLASS, INC36add3a3-f1ff-3986-e063-6394a90ab7fe2025-12-15Exact identifier
application number: M020
Antioxidant Mineral Sunscreen Plus Primer Lightly TintedZINC OXIDETrue Beauty Brows & Skin Care37dc70ba-a6bb-fe09-e063-6394a90a51292025-12-15Exact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCbcbab676-fbe2-f0cc-e053-2a95a90ad4d22025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14cf2b8-b110-1210-e053-2995a90a01022025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf1504311-4865-5499-e053-2995a90acdcd2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC CLEARSCREEN SUNSCREEN SPF100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCf14d70f1-440b-900d-e053-2995a90a30a02025-12-15WarningsExact identifier
application number: M020
REVERSE Brightening Defense FluidAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsdc230e1e-bfb8-4d7c-bad5-bff77d78220e2025-12-15WarningsExact identifier
application number: M020
COOLA BARE REPUBLIC MINERAL SPORT SPF50TITANIUM DIOXIDE, ZINC OXIDECOOLA, LLCbbf15e58-c160-d599-e053-2a95a90a06962025-12-14WarningsExact identifier
application number: M020
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020
COOLA CLASSIC SUNSCREEN FRAGRANCE FREEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCcfc21b1a-4a26-1573-e053-2995a90a2d502025-12-14WarningsExact identifier
application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKopari Beauty7c96b799-e24d-473f-8f0a-3fad83d5ed482025-12-14WarningsExact identifier
application number: M020
WOODSLEEP Sunscreen BalmTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.45cfc7ed-34a6-1f45-e063-6394a90a902b2025-12-13WarningsExact identifier
application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50ZINC OXIDE 24%UNIVERSKIN45d242de-cbd8-e7ea-e063-6394a90aaebf2025-12-13WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50ALAINA HEALTHCARE PRIVATE LIMITEDb7847d4f-2517-4b58-8e31-676c9d6e484d2025-12-12WarningsExact identifier
application number: M020
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
application number: M020
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC40323dfa-29e4-1464-e063-6294a90aa65c2025-12-12WarningsExact identifier
application number: M020
Zinc 20Percent SPF 40ZINC OXIDEJOHANNA'S SKIN CARE3545ed3e-b42f-d29d-e063-6394a90a8efe2025-12-12Exact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC40332cf3-e4e5-0c00-e063-6394a90a683d2025-12-12WarningsExact 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