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 324 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Personalized Day Moisturizer with SPFTITANIUM DIOXIDE, ZINC OXIDEProven Skincare3b6546ed-22ee-48e6-83cc-5cbadf5674992023-11-10WarningsExact identifier
application number: M020
Proven Personalized Day Moisturizer With SPF 50ZINC OXIDEProven Skincareba9b3cdc-c237-7ce2-e053-2995a90ac1752023-11-10WarningsExact identifier
application number: M020
MIAMI BEACH BUM Save Face SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM538742bc-d8f3-47d9-a85f-f2b1314f55072023-11-10WarningsExact identifier
application number: M020
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)TITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4935f888-cd92-61d1-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a507-863f-1088-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
CoralSafe Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDEElements Brandse6e00896-b7e5-41c6-a72b-08e600758cf52023-11-10WarningsExact identifier
application number: M020
Coral Safe SPF-30 Broad Spectrum SunscreenTITANIUM DIOXIDE, ZINC OXIDEElements Brands, Inc.4925a3ad-6379-108a-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M020
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolfb677ad0-2791-44ec-9720-951471ec009a2023-11-09WarningsExact identifier
application number: M020
Shaklee Youth Age Defense Mineral Moisturizer SPF 30TITANIUM DIOXIDEShaklee Corporationf4888fdc-09f9-43de-8c81-5a0f5e767d4e2023-11-09WarningsExact identifier
application number: M020
Raw Elements Eco 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLCbcce6d5b-d641-4484-a4dd-06b81170f8632023-11-09WarningsExact identifier
application number: M020
Spit and Polish Mineral Face SPF 30ZINC OXIDENaturally Uncommon, LLCaf86fca8-571c-0cac-e053-2a95a90ae4022023-11-09WarningsExact identifier
application number: M020
Raw Elements Tint 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC801a616a-5007-4951-8bc5-b8ffe9f0bb192023-11-09WarningsExact identifier
application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30ZINC OXIDERaw Elements LLCfda8fce8-a164-45b5-b6ca-b1efce4740892023-11-09WarningsExact identifier
application number: M020
Raw Elements Lip Rescue 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC74b8eac3-4bc6-430b-b4b9-eabe3280d7af2023-11-09WarningsExact identifier
application number: M020
Raw Elements Baby Kids Broad Spectrum SPF30 SunscreenZINC OXIDERaw Elements LLCa6e5f808-65c7-4810-a15c-413111216dae2023-11-09WarningsExact identifier
application number: M020
Raw Elements Eco Formula 30 Broad Spectrum SPF 30ZINC OXIDERaw Elements LLC1d130543-9e12-42f4-80b4-915dbe0f85d42023-11-09WarningsExact identifier
application number: M020
Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad SpectrumZINC OXIDERaw Elements LLC8aff5517-8b3d-490e-b821-973baea2d0792023-11-09WarningsExact identifier
application number: M020
Raw Elements Daily Moisturizer Broad Spectrum SPF30ZINC OXIDERaw Elements LLC92c5f11b-5585-4479-8ee3-315c7e72574f2023-11-09WarningsExact identifier
application number: M020
Big Mood SPF 30 Milky Lip BalmZINC OXIDEEveryday Group Limitedc83098af-3cf9-78f6-e053-2995a90a0d012023-11-09WarningsExact identifier
application number: M020
Spit and Polish Sun Smart SunscreenTITANIUM DIOXIDE, ZINC OXIDENaturally Uncommon, LLCaf879a05-1483-5c11-e053-2995a90af45d2023-11-09WarningsExact 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