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 300 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Berry SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEco Lips. Inc.e5e84e60-4339-460d-e053-2a95a90ad1522024-04-17WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Mint SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEEco Lips. Inc.e64c4a2d-134e-999a-e053-2a95a90a64ee2024-04-17WarningsExact identifier
application number: M020
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
application number: M020
Differin Oil Absorbing Moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.4d5978c7-3575-4b5b-97bd-5f3c89412baf2024-04-17WarningsExact identifier
application number: M020
Cancer Council Everyday Active SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16381c8f-f954-f0be-e063-6394a90ae4012024-04-16WarningsExact identifier
application number: M020
The Nethercutt Collection Sunscreen Stick SPF 30 Broad Spectrum Sunscreen SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.163a2994-d95a-5752-e063-6394a90aec5d2024-04-16WarningsExact identifier
application number: M020
The Nethercutt Collection Hemp Vanilla SPF 30 Broad Spectrum Sunscreen Lip Balm SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.163ac1c1-7403-9d60-e063-6294a90a1cc02024-04-16WarningsExact identifier
application number: M020
CetaphilOCTOCRYLENE, AVOBENZONEGalderma Laboratories, L.P.2a6bc3f2-4e52-252b-d051-94be1ee0cc002024-04-16WarningsExact identifier
application number: M020
Cetaphil Oil Absorbing SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.73ed545b-460f-4287-8643-a02b0641fd452024-04-16WarningsExact identifier
application number: M020
SUN CONTROL BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, ZINC OXIDESKINPLAN.US LLC8e34a343-7253-469f-9973-076a7ae26cbc2024-04-15WarningsExact identifier
application number: M020
Cancer Council Protect and Hydrate Radiance SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.1622c351-6e69-eeaf-e063-6294a90acd252024-04-15WarningsExact identifier
application number: M020
Hydrating Mineral Sunscreen BS SPF30ZINC OXIDEAllure Labs16268c31-2151-20e0-e063-6294a90a79652024-04-15WarningsExact identifier
application number: M020
Cancer Council Daily Body Moisturizer SPF50 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVitality US Co.16296d3e-286a-e015-e063-6394a90a41892024-04-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Productionf9645435-e138-45df-a5ec-6dc7b3ff792d2024-04-08WarningsExact identifier
application number: M020
Degil Sun SPF 50 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc155aa0c5-6403-ee86-e063-6294a90a1c4d2024-04-05WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip SPF 15 AssortedHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECarma Laboratories, Inc.ff9eae5b-4963-429d-bb73-8e3b5402f0842024-04-05WarningsExact identifier
application number: M020
Lemongrass Spa Products SPF 45 Mineral SunscreenZINC OXIDELemongrass Spa Products15469260-d4e5-8423-e063-6394a90aafae2024-04-04WarningsExact identifier
application number: M020
Clearly Zinq Tinted Hydrating Facial SPF Growth Factor 35ZINC OXIDEAllure Labs1548faf9-8623-f871-e063-6394a90a931f2024-04-04WarningsExact 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