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 326 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
application number: M020
Aruba Sun SPF 70 SunscreenAVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%Derma Care Research Labs, LLCd96b4233-6d52-7621-e053-2a95a90a1b602023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
application number: M020
Dead Sea Natural Face Moisturizer Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltddee4bdb8-5c6f-42f6-b15c-d109cd2d31402023-11-08WarningsExact identifier
application number: M020
Mineral Radiance Energizing Day BS SPF 15AVOBENZONE, HOMOSALATE, AND OCTISALATEAHAVA Dead Sea Laboratories Ltd4cb8b21c-7727-441a-9d61-c90d79ac45dc2023-11-08WarningsExact identifier
application number: M020
Jack Black Intense Therapy Lip Balm Passion FruitAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLCf34beb68-e5dc-45c4-a6d1-e9a0310162282023-11-08WarningsExact identifier
application number: M020
Private Label SPF45 Water Resistant Paraben Free SunscreenOCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCf997f4fc-7da5-433c-9a53-2030b489b4f62023-11-07WarningsExact identifier
application number: M020
Private Label Moisturizing Oil Free Paraben Free SPF43SUNSCREENSwiss-American CDMO, LLC003e4221-f9d9-47c4-b10b-9876046b931a2023-11-07WarningsExact identifier
application number: M020
AHAVA ACTIVE DEADSEA MINERALS TIME TO ENERGIZE AGE CONTROL MOISTURIZING BROAD SPECTRUM SPF15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAHAVA Dead Sea Laboratories Ltd5a9ec221-a9ec-4473-8fb0-83f10ae775e22023-11-07WarningsExact identifier
application number: M020
Private Label Super Light Oil-Free SPF452.75% OCTINSALATE, 7.50% OCTINOXATE, 8.00% ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC6a08448a-46bc-4330-ae2d-f716bb4edfa72023-11-07WarningsExact identifier
application number: M020
GOLD MOUNTAIN BEAUTY Collagen Broad Spectrum SPF 30OCTINOXATE, OCTISALATE, ZINC OXIDETT Fitness, Inc617ef3af-4203-4664-b714-1b5fab2e0ee62023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Clear Moisture Mineral SPF-30ZINC OXIDEThe Seaweed Bath Co.c241261c-d887-4ac2-89ce-93dcc0fce2672023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Let It Sun Sunscreen SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC88628c11-dbc7-4404-9701-7944a685a13d2023-11-06WarningsExact identifier
application number: M020
SEAWEED BATH CO. Sheer Mineral Sensitive SPF-50ZINC OXIDEThe Seaweed Bath Co.fdcfc7eb-da33-4461-a4f9-fe97ea6b873f2023-11-06WarningsExact identifier
application number: M020
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
application number: M020
CALIFORNIA MANGO SPF-50 SUNSCREENAVOBENZONE, OCTISALATE, OCTOCRYLENECALMANGO, INC183e523a-93ee-47ec-8bd4-5557af449ea52023-11-06WarningsExact identifier
application number: M020
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
application number: M020
JESS BEAUTY Sun Drops Sunscreen Oil SPF-50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEJESS BEAUTY PRODUCTS LLC4e05e9d6-5127-44ca-a331-3004b2ddb5342023-11-06WarningsExact 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