FDA.reportPublic FDA data

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 332 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRIDEFUL SPF 15 LIP BALM-passion fruitHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCd6b6389b-c8bd-4aca-8ccf-455dbc22070d2023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-coconutHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCa6af5cdc-999d-45ba-a7a6-5e7330f8b9c02023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-melonHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCe201fec6-eb69-40fb-8459-02d64e34a3b72023-10-26WarningsExact identifier
application number: M020
PRIDEFUL SPF 15 LIP BALM-orange mangoHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEPRIDEFUL LLCc50c9f00-6a0f-4307-b35d-7fc5fa3b7edf2023-10-26WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLCe5fcb1fd-ad61-1ea5-e053-2a95a90a24722023-10-26WarningsExact identifier
application number: M020
Grape Soda SPF 15 Broad Spectrum Lip BalmGRAPE SODA SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca09a0b5f-93e4-d18a-e053-2a95a90a65f72023-10-26WarningsExact identifier
application number: M020
Beeswax SPF 30 Broad Spectrum Lip BalmBEESWAX SPF 30 BROAD SPECTRUM LIP BALMRaining Rose, Inca962bfca-03a3-8dde-e053-2a95a90abbb92023-10-26WarningsExact identifier
application number: M020
CreamZINC OXIDEOxygen Development LLC08a1e862-b55a-fb84-e063-6294a90a016a2023-10-26WarningsExact identifier
application number: M020
SIMPLE TRUTH MINERAL BASED SPF 50 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDETHE KROGER COMPANYa52872bf-cd0f-06da-e053-2995a90af28d2023-10-26WarningsExact identifier
application number: M020
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08a36887-3997-8fff-e063-6394a90ae9d52023-10-26WarningsExact identifier
application number: M020
PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEESTEE LAUDER INCe87c4a76-5f21-4989-a1e0-0b7c6902f2012023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Unflavored Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN UNFLAVORED LIP BALMRaining Roseefe20472-aa84-1cb4-e053-2a95a90abfd82023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN MINT LIP BALMRaining Roseefe1113b-6101-0c15-e053-2a95a90a02a72023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Tropical Smoothie Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN TROPICAL SMOOTHIE LIP BALMRaining Roseefe176f7-9c11-106e-e053-2a95a90a9c882023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Citrus Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN CITRUS LIP BALMRaining Roseefdfc182-3ac0-1a3d-e053-2a95a90a894e2023-10-26WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Iced Pear Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN ICED PEAR LIP BALMRaining Roseefe01abd-0ee2-6bd6-e053-2a95a90a123d2023-10-26WarningsExact identifier
application number: M020
Diamond Luminous UV Defense Light Tinted Fluid Sunscreen Broad Spectrum SPF 40TITANIUM DIOXIDE, ZINC OXIDENATURA BISSE INTERNATIONAL SAbf8b71c7-257b-0eb6-e053-2a95a90a3a4c2023-10-26WarningsExact identifier
application number: M020
Carmex Weather Guard Moisturizing Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMCarma Laboratories, Inc.843677f2-78fa-4f3d-9fe6-e45e35b728e32023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Cupcake Batter SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baec9be7-5ae6-135c-e053-2995a90a2ed42023-10-25WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm Fresh Cherry SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.baea3596-6eb0-4d98-e053-2995a90a75cc2023-10-25WarningsExact 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