FDA.reportPublic FDA data

Vacation Lip Balm

Product NDC
80641-520
11-digit product format
806410520
Labeler code
80641
Product ID
80641-520_7d6947d5-8d03-4bf2-8ca7-0847efa7c0cc
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
2026-01-01
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
b442530f-cae3-418b-9675-c18879653826Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-520-01Vacation 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 337 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Beauty Balm Perfecting Primer SPF 35 Broad Spectrum SunscreenENSULIZOLE, OCTINOXATE, ZINC OXIDEAmway Corp6aaec5a4-701e-4870-896d-f68f62448c7a2023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation SPF 15 Broad Spectrum SunscreenTITANIUM DIOXIDEAmway Corpa83f1192-c6c7-4145-b5af-29202191db782023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Buff L1W1TITANIUM DIOXIDEAmway Corpcba2462d-71ec-4ecb-b05a-5208ff8e22ad2023-10-21WarningsExact identifier
application number: M020
ARTISTRY YOUTH XTEND Lifting Smoothing Foundation Broad Spectrum SPF 20 SunscreenOCTINOXATE, OXYBENZONEAmway Corp8cde14ae-b886-4bd2-b2bd-db604373984a2023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Brule L4W1TITANIUM DIOXIDEAmway Corp19d08a86-5a60-4633-8a3c-96bab9a17fcc2023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Chablis L1C1TITANIUM DIOXIDEAmway Corpd17b1d46-478e-4f48-8fde-ac639bcdc4922023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Chiffon L2C1TITANIUM DIOXIDEAmway Corp750ca57c-e8e9-4be0-84b1-7f55487f7bf62023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cream L1W2TITANIUM DIOXIDEAmway Corp192dac09-2887-4622-b3d4-c6a9c16b4f882023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Mink L6W1TITANIUM DIOXIDEAmway Corpaf6d38d5-69ab-4d7e-b534-b2c2bcf368472023-10-21WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Ochre L2N1TITANIUM DIOXIDEAmway Corp7f545d32-b38c-4f6a-a413-7f29e1aa2bc32023-10-21WarningsExact identifier
application number: M020
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZERAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONECLINIQUE LABORATORIES LLC2e9463df-1c71-465f-9820-6cedefe07ad72023-10-20WarningsExact identifier
application number: M020
EVEN BETTER SKIN TONE CORRECTING MOISTURIZER BROAD SPECTRUM SPF 20AVOBENZONE, OCTISALATE, AND OCTOCRYLENECLINIQUE LABORATORIES LLC2ccf568b-b8ff-414d-b15d-0cab6a57a8012023-10-20WarningsExact identifier
application number: M020
CL EB MATTE MAKEUP BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC082b297e-d1d9-16b2-e063-6294a90a2ffd2023-10-20WarningsExact identifier
application number: M020
Farmasi BB Cream LIGHT to MEDIUM 02TITANIUM DIOXIDETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI062ffd88-2016-3c4d-e063-6394a90a5cf92023-10-20WarningsExact identifier
application number: M020
Usana Celavive Daily Mineral Protective Cream Moisturizer with Sunscreen SPF 30ZINC OXIDEUSANA Health Sciences, Inc.c10c188c-66e0-18ec-e053-2a95a90a5a7d2023-10-19WarningsExact identifier
application number: M020
SUPERDEFENSE BROAD SPECTRUM SPF 25 FATIGUE PLUS 1ST SIGNS OF AGE MULTI-CORRECTING VERY DRY TO DRY COMBINATIONAVOBENZONE, HOMOSALATE, AND OCTISALATECLINIQUE LABORATORIES LLCb0e9edb6-0bc6-4e5b-93ab-b3bdbf3f8be02023-10-19WarningsExact identifier
application number: M020
CLINIQUE EVEN BETTER CLINICAL SERUM FOUNDATION BROAD SPECTRUM SPF 25TITANIUM DIOXIDE, ZINC OXIDECLINIQUE LABORATORIES LLC884abba1-891d-4c3c-b203-38a5a8a577562023-10-19WarningsExact identifier
application number: M020
MARA Algae Zinc Sea Kale Sunscreen Serum SPF 30ZINC OXIDEMara Beauty LLCba986280-eea3-b49c-e053-2995a90a39572023-10-19WarningsExact identifier
application number: M020
Valmont Daily Veil. Moisturizing Face Fluid Mineral SunscreenZINC OXIDEInnovation Labs, Inc.87a4b9c0-c33d-4bde-b455-dc8c33d8bb9c2023-10-18WarningsExact identifier
application number: M020
Broad Spectrum SPF 15 Sunscreen Vanilla Mint Lip BalmBROAD SPECTRUM SPF 15 SUNSCREEN VANILLA MINT LIP BALMRaining Roseefe25551-777c-5336-e053-2a95a90a5c232023-10-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-520-018064105200115 mL in 1 TUBE (80641-520-01) 15 ml2026-01-01NoNoCurrent