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 302 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLVADERM Dermaxsol Dermal Defense Moisturizer SPF-30OCTOCRYLENE, ZINC OXIDESOLVADERM LLC0f9a507a-1b72-45f8-a8a8-b7a92a85607f2024-03-21WarningsExact identifier
application number: M020
Daily Prevention Protect and Refresh Mist SPF 40AVOBENZONE, OCTISALATE AND OCTOCRYLENEAllure Labs142f99de-176e-ad11-e063-6394a90a935b2024-03-21WarningsExact identifier
application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEfmg Co.Ltd1410c6d9-eff0-f90b-e063-6394a90a94032024-03-20WarningsExact identifier
application number: M020
ETADERM Tattoo Sunscreen Broad Spectrum SPF-30ZINC OXIDENUEPHASE LLCcc1e3485-57e6-4ac9-96b3-2d683beb5b532024-03-20WarningsExact identifier
application number: M020
Daily Prevention Advanced Smartblend Mineral Moisturizer SPF 75TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs141bb721-cd1c-5bba-e063-6394a90ab8fa2024-03-20WarningsExact identifier
application number: M020
Sunscreen-LotionZINC OXIDE, TITANIUM DIOXIDEShanghai Chuangshi Medical Technology (Group) Co., Ltd.0511ff57-b7bd-4708-e063-6294a90a58a82024-03-20WarningsExact identifier
application number: M020
Daily Prevention Ultra Defense Moisturizer SPF 50HOMOSALATE, OCTISALATE,OCTOCRYLENE AND ZINC OXIDEAllure Labs14070076-8c57-e2f1-e063-6394a90a0dfc2024-03-19WarningsExact identifier
application number: M020
PHYSIOGEL Daily Moisture Therapy Barrier Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDELG H&H Co., Ltd.140feb1e-a72f-ade4-e063-6394a90a11fb2024-03-19WarningsExact identifier
application number: M020
Daily Prevention Sheer Matte Moisturizer SPF30HOMOSALATE AND OCTISALATE AND ZINC OXIDEAllure Labs13b5c78c-f950-699b-e063-6294a90a98982024-03-15WarningsExact identifier
application number: M020
Daily Prevention Pure Mineral Tinted Moisturizer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAllure Labs13bc141b-a30f-2661-e063-6294a90aca2b2024-03-15WarningsExact identifier
application number: M020
BB Ambre 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13a3ec97-0d0a-d639-e063-6294a90a0bf82024-03-14WarningsExact identifier
application number: M020
Mineral ShakeZINC OXIDEVacation Inc.131b7e65-7155-f925-e063-6394a90a1d7a2024-03-13WarningsExact identifier
application number: M020
BB Blanc 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137a1528-c487-8bf3-e063-6294a90ade842024-03-12WarningsExact identifier
application number: M020
BB Sienna 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs137bff4a-5156-b12c-e063-6394a90abe632024-03-12WarningsExact identifier
application number: M020
Vacation SuperAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.137c350b-dca1-47f7-e063-6294a90a531e2024-03-12WarningsExact identifier
application number: M020
Avene Hydrance Moisturizing SPF 30ZINC OXIDEPierre Fabre USA Inc.1361ebe5-2659-d88f-e063-6294a90a71bb2024-03-11WarningsExact identifier
application number: M020
BB Brite 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13660aee-3b28-7e3e-e063-6294a90a82cc2024-03-11WarningsExact identifier
application number: M020
BB Bronze 30 BS SPF30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs13679e50-01ef-9a8f-e063-6294a90ac5772024-03-11WarningsExact identifier
application number: M020
Advanced Firming And Anti-Wrinkle Day SPF 18 EQBAVOBENZONE 2% OCTISALATE 5% OCTOCRYLENE 5%Walmart358dfed4-1c6d-400e-8e6f-331fbc76a8342024-03-11WarningsExact identifier
application number: M020
Avene Mineral Sunscreen Stick SPF 50ZINC OXIDEPierre Fabre USA Inc.1368482f-3a72-ffa9-e063-6394a90a603e2024-03-11WarningsExact 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