Vacation Lip Balm

Product NDC
80641-720
11-digit product format
806410720
Labeler code
80641
Product ID
80641-720_3f30fa27-3289-4cab-bf11-d54fa5d05cf7
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
2026-03-15
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
4ba8ed52-2f52-40b9-a810-8450f9b90778Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-720-01Vacation 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 13 of 361 · 7,213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACHZINC OXIDECOSMAX USA, CORP564749f3-e820-9003-e063-6294a90a02652026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRALZINC OXIDECOSMAX USA, CORP56477f58-3878-81fa-e063-6294a90a87b72026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP WRMZINC OXIDECOSMAX USA, CORP5647ae2c-bcba-63c0-e063-6394a90ad5bc2026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP WRMZINC OXIDECOSMAX USA, CORP56478f3d-f25c-bef7-e063-6294a90ade092026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 TAN DEEP COOLZINC OXIDECOSMAX USA, CORP564796f8-072f-61f2-e063-6394a90ab3942026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP COOLZINC OXIDECOSMAX USA, CORP5647e63c-a695-1b40-e063-6394a90a57672026-07-10WarningsExact identifier
application number: M020
VERSED MULTI SERUM SKIN TINT SPF 40 DEEP NEUTRALZINC OXIDECOSMAX USA, CORP5647d0f1-945f-b0b7-e063-6294a90aafe22026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset SandsZINC OXIDECOSMAX USA, CORP5648da76-5a67-605a-e063-6294a90a4e3b2026-07-10WarningsExact identifier
application number: M020
Coco and Eve Tan Boosting Anti Aging Body Oil SPF 45HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECOSMAX USA, CORP5648d637-9743-97a7-e063-6294a90ad8a12026-07-10WarningsExact identifier
application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Vanilla CloudZINC OXIDECOSMAX USA, CORP5648c90b-b814-c16e-e063-6394a90a3e1f2026-07-10WarningsExact identifier
application number: M020
The Mineral Lip One SPF 45 Nourishing Lip Tint Berry BalmyZINC OXIDECOSMAX USA, CORP56490982-200d-e3a7-e063-6394a90a72a42026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Warm SiennaZINC OXIDECOSMAX USA, CORP56491794-712d-1306-e063-6394a90a47072026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Bright BerryZINC OXIDECOSMAX USA, CORP56491833-5053-c85e-e063-6294a90ac4f52026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Nude RoseZINC OXIDECOSMAX USA, CORP56493964-1d5b-2fc7-e063-6394a90a74922026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Soft PetalZINC OXIDECOSMAX USA, CORP5649df7b-9d2c-d8eb-e063-6394a90acf992026-07-10WarningsExact identifier
application number: M020
PRIME Prometics LipOil SPF 35 Nude GlowZINC OXIDECOSMAX USA, CORP564a6566-442c-b933-e063-6294a90a6f9b2026-07-10WarningsExact identifier
application number: M020
SOFIE PAVITT FACE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA., CORP564ae5d2-1504-9623-e063-6394a90a2fa52026-07-10WarningsExact identifier
application number: M020
IDEALOVE HYDROGLOW DAILY SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA, CORP564b284c-3248-c6c0-e063-6394a90a11032026-07-10WarningsExact identifier
application number: M020
SOFIE PAVITT FACE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATECOSMAX USA., CORP564b1ed2-aa98-a334-e063-6294a90a169b2026-07-10WarningsExact identifier
application number: M020
LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 GOLDEN HOURZINC OXIDECOSMAX USA, CORP564b559e-6fe8-e98e-e063-6294a90a8f0e2026-07-10WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-720-018064107200115 mL in 1 TUBE (80641-720-01) 15 ml2026-03-15NoNoCurrent