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 107 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
application number: M020
Sunscreen StickHOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%Foshan Sugar Max Cosmetics CO.,Ltd4637503c-46dc-68de-e063-6394a90abdc72025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe78c9ae0-c2ef-12ce-e053-2995a90abf1c2025-12-18WarningsExact identifier
application number: M020
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company248be719-edff-f40d-e063-6394a90a4ef62025-12-18WarningsExact identifier
application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company59187729-c166-58fe-e053-2991aa0abe472025-12-18WarningsExact identifier
application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60a304b1-eee5-408b-e053-2a91aa0a0a082025-12-18WarningsExact identifier
application number: M020
THE BOD GUARD Invisible Gel Sunscreen for BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.463fa1ef-d40d-d818-e063-6294a90a5e612025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN CLEAR WEIGHTLESS HYDRATION SPF70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe686a22f-bddc-5d7c-e053-2995a90a7b282025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC090904d1-c04c-3fca-e063-6294a90a7cc72025-12-18WarningsExact identifier
application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 FairTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb098aba3-dad6-4421-a943-e88ce5e2f8d62025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep MochaTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb3260833-8b7c-4d88-a55a-8cef4938442d2025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral RichTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC0a647c9a-2c71-4cd2-9503-e9ab96b857ee2025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeepTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf246553e-17c2-4dba-855b-1942646bb8342025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep BronzeTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC15de58a4-e2bc-425b-b50b-df2d87dd3bb42025-12-18WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCf493c3ea-41b3-4625-84a6-fab545a769402025-12-18WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC472f34c5-cefe-4884-9475-fd0666c925ac2025-12-18WarningsExact identifier
application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Companyd7238996-374b-07aa-e053-2995a90ae8892025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Companyeadacdae-3901-3f7c-e053-2a95a90ab1842025-12-18WarningsExact 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