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 71 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 241HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.a100b05a-06b7-4c65-9822-3f62ca029f402026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 331HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.c3dd293c-8819-4406-af60-41b632a8c00f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 342HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.99a92fc5-9a3e-434a-9a5b-3cc47efeea532026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 351HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e6cd9c7a-29ef-4132-a3e5-575dddb36a9e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 421HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.ea630f2c-49a7-4900-a0ac-b0e1c554aff92026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 430HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.cc9c9b69-a0ea-44ac-a590-2cd241ce31622026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 442HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.e38a10a8-73ac-4fc5-bbde-537ccb845e6f2026-01-22WarningsExact identifier
application number: M020
Designer Lip Smoothie SPF 15 Lip BalmAVOBENZONE, OCTISALATE, HOMOSALATE, PETROLATUMAustralian Gold6fd1bd4f-ef94-42b5-a26c-2a02718c113f2026-01-22WarningsExact identifier
application number: M020
Australian Gold SPF 15 Lip BalmOCTINOXATE, OCTOCRYLENE, OXYBENZONE, OCTISALATE, PETROLEUM JELLYAustralian Gold92966c2d-b61a-4f8b-a5c1-8dfb6352c82f2026-01-22WarningsExact identifier
application number: M020
LEBELAGE UV SUN ULTRA SHIELD SUN SCREENLOTION 50gAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, OCTISALATEDONGDONGGURIMOO CO.,LTD.4907eb9c-3978-27ed-e063-6394a90a9f662026-01-22WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.be9f7608-cfaa-4b16-83dd-0580047af56c2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6b27df44-c441-4ae8-a1b0-a9cf2fff6f212026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3c295f6b-6202-a2e1-e063-6394a90a9a602026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.b2eee48f-b644-403c-a57e-04a1491bc3862026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ebcc2c6c-a039-48d5-8c1c-5b347254c4c22026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6967f8bc-3092-44a9-926a-6c11676425e52026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.37d4d8c1-e76b-48a3-9a13-f0543af1b28f2026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact 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