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 292 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bitchstix Very Raspberry SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchstix, LLC1d77e9c3-cffe-0bb6-e063-6294a90aacd12024-07-17WarningsExact identifier
application number: M020
Bitchstix The Original SPF 30 Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEBitchistix, LLC1d78148a-586c-2f7d-e063-6294a90a46912024-07-17WarningsExact identifier
application number: M020
Derma E Sun Defense Face SPF 30ZINC OXIDE TITANIUM DIOXIDEderma ed90b8f81-de7a-4022-800a-90f063e941802024-07-17WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreenTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1d611494-648b-6e5f-e063-6294a90a45002024-07-16WarningsExact identifier
application number: M020
CVS Beauty 360 7-in-1 Complete Daily Moisturizer Anti-Aging Formula with Broad Spectrum SPF 15 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfa412c9d-2a8b-bf71-e053-6394a90a8a632024-07-16WarningsExact identifier
application number: M020
CVS Health SPF 50 ClearAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECVS PHARMACYf42402ff-0d70-9231-e053-2995a90aa46d2024-07-16WarningsExact identifier
application number: M020
CVS Health Sunburn Relief CoolingLIDOCAINE HYDROCHLORIDECVS PHARMACY1d6402ea-4201-27f9-e063-6294a90a43f52024-07-16WarningsExact identifier
application number: M020
NYX Professional Makeup Blurscreen Primer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc6ca01ccb-07f8-4d2c-84bb-6b251e73dad22024-07-16WarningsExact identifier
application number: M020
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc8df98d97-a5d2-4d52-8bd2-130a13501d602024-07-16WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC1d4cab02-8897-6449-e063-6294a90ad72e2024-07-15WarningsExact identifier
application number: M020
the beach people SPF 50ZINC OXIDEThe Beach People United LLC2e5176e2-e2f4-4b08-8528-cb1ee3c166592024-07-15WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production23235897-c1fc-423f-99a2-e2ad282ee7442024-07-14WarningsExact identifier
application number: M020
LOreal Paris Bright Reveal Broad Spectrum SPF 50 Daily UV SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc96d72471-de95-4668-8903-aed6187633a92024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDECosmetique Active Productiona3b5dfe5-c726-4f9c-8e4d-0e9808480d4b2024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil UV Age Daily Sunscreen Broad Spectrum SPF 60TITANIUM DIOXIDELOreal USA Products Inc2e85cf6e-a2a7-4871-bdb6-1d72088c30312024-07-14WarningsExact identifier
application number: M020
Vichy Laboratoires Mineral 89 Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc664c67cc-7d63-45d7-abdd-157c041b0d3f2024-07-14WarningsExact identifier
application number: M020
SkinCeuticals Clear Daily Soothing UV Defense Daily Sunscreen Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDEL'Oreal USA Products Inc817c882d-72f3-4ee7-8da2-a4a32f9d167f2024-07-14WarningsExact identifier
application number: M020
Sun Wrangler Daily Mineral Sunscreen SPF 45ZINC OXIDESun Wrangler1d0e94f1-2996-c058-e063-6294a90a343b2024-07-12WarningsExact identifier
application number: M020
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
application number: M020
the beach people SPF 30ZINC OXIDEThe Beach People United LLC3a7cc69a-6027-4dfd-b9ef-9d4390fe630c2024-07-12WarningsExact 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