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 85 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
application number: M020
Glow Screen Body Broad Spectrum Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCb9590938-417d-617a-e053-2995a90a74962026-01-09WarningsExact identifier
application number: M020
100% Mineral Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd7758651-c152-5868-e053-2a95a90ab6732026-01-09WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 30ZINC OXIDESupergoop, LLC4cf243b4-d794-401a-b209-18c7e550ef4f2026-01-09WarningsExact identifier
application number: M020
Daily Dose Bioretinol Mineral SPF 40ZINC OXIDESupergoop, LLCeb5bbc70-dbdf-06a8-e053-2995a90a66c12026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Body SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCec1c30bd-76e1-9d00-e053-2a95a90a17592026-01-09WarningsExact identifier
application number: M020
Glow Screen SPF 40AVOBENZONE, OCTISALATE, OCTOCYLENESupergoop, LLC21569637-332a-461b-bf6c-33af6a83a1552026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 - DawnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf07145d5-b74d-7757-e053-2a95a90ac4c02026-01-09WarningsExact identifier
application number: M020
Glowscreen SPF 40 -SunsetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCf7e493da-8fc6-191d-e053-6294a90aa4832026-01-09WarningsExact identifier
application number: M020
Supergoop Glow Screen SPF 40 Shade 2 Golden HourBROAD SPECTRUM SUNSCREENSupergoop LLCd2928dd7-a813-4929-e053-2a95a90aaeb42026-01-09WarningsExact identifier
application number: M020
Superscreen Hydrating Daily Cream SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCff0e4e97-8f01-bd36-e053-6394a90a47ae2026-01-09WarningsExact identifier
application number: M020
Lipshade SPF 30 Hey YallZINC OXIDESupergoop, LLCf93dfa13-ff18-ee38-e053-6394a90aea462026-01-09WarningsExact identifier
application number: M020
Triple Prep SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATESupergoop, LLC004df4e5-dba9-6030-e063-6394a90a76d32026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Lip Protector SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC12605fb4-0de6-94f3-e063-6294a90a3a6f2026-01-09WarningsExact identifier
application number: M020
Unseen Sunscreen Stick SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLC2735c5c7-a4ef-33c3-e063-6294a90abf972026-01-09WarningsExact identifier
application number: M020
PLAY Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONESupergoop LLC2860d42c-d644-8b5a-e063-6394a90aec102026-01-09WarningsExact identifier
application number: M020
PLAY Mineral SPF 30 with Green AlgaeZINC OXIDESupergoop LLC29a1ff4b-3875-5275-e063-6394a90a53fd2026-01-09WarningsExact identifier
application number: M020
Every. Single. Face. Watery SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESupergoop, LLCd086a9b8-19e5-f713-e053-2995a90aa9762026-01-09WarningsExact identifier
application number: M020
3D Tinted Moisturizing BS SPF 30ZINC OXIDEAllure Labs47fd415f-819e-bbb8-e063-6394a90a2c6a2026-01-09WarningsExact identifier
application number: M020
ST MORIZ SUNCARE BODY SUNSCREEN SPF50SUNCARE BODY SUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.4801cfd2-1fe2-d118-e063-6294a90a6c8b2026-01-09WarningsExact 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