FDA.reportPublic FDA data

Vacation Face

Product NDC
80641-031
11-digit product format
806410031
Labeler code
80641
Product ID
80641-031_67065a12-6930-423b-a1b0-25f356e6b11b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, and Octocrylene
Dosage form
LOTION
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; 10; 5; 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 Face
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE10 g/100mL
OCTISALATE5 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
14b8a3cf-031c-4c52-ba81-e683e69d0f37Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-031-89Vacation Face89 mL in 1 BOTTLE, DISPENSINGLOTION891

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 342 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
application number: M020
Thinksport Clear Zinc SPF 50ZINC OXIDEthinkOperations,LLCb5ce523f-eee8-f1a8-da19-b3dc14f8a58e2023-05-31WarningsExact identifier
application number: M020
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
application number: M020
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreeninted SPF 50ZINC OXIDETopiderm, Inc.46c6f20f-4bb6-47c6-9eac-17ca97bb14a72023-03-20WarningsExact identifier
application number: M020
Replenix Sunscreen SPF 50ZINC OXIDETopiderm, Inc.9223ffa8-7af3-4407-9170-482afec536d82023-02-24WarningsExact identifier
application number: M020
Bath and Body Works SPF20 Coconut Lip BalmSPF20 LIP BALMAutumn Harpf5744a48-2b39-4949-e053-2a95a90ab15d2023-02-24WarningsExact identifier
application number: M020
Replenix Tinted Sunscreen SPF 50ZINC OXIDE AND OCTINOXATETopiderm, Inc.1fda4a54-e323-4f3c-b659-bded4b1b3dd02023-02-22WarningsExact identifier
application number: M020
Topix Mineral Mattifying Tinted Sunscreen SPF 50ZINC OXIDETopiderm, Inc.ac5bbf3f-e1e0-4e03-bc5a-d6029dfb4e912023-02-22WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
application number: M020
Essential Moisturizing SunscreenZINC OXIDE, OCTINOXATETopiderm, Inc.450d916e-4c77-489e-86b1-78b6863554762023-02-09WarningsExact identifier
application number: M020
Mineral Repair SPF 45ZINC OXIDETopiderm, Inc.84580f10-3119-4253-87a6-53d24a1f22272023-02-07WarningsExact identifier
application number: M020
Think Aloe and Tea Leaves Zinc oxideZINC OXIDEthinkOperations,LLC9965ccd1-821d-4d9d-8a56-e87440b809ee2023-02-02WarningsExact identifier
application number: M020
Replenix Lip Therapy homosalateHOMOSALATETopiderm, Inc.b60dc004-d713-47bc-a6e9-ea4783aa70192023-02-02WarningsExact identifier
application number: M020
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
application number: M020
Tinted Lip Balm SPF30 Wild PeonySPF30 LIP BALMAutumn Harpd0604720-623a-e8a9-e053-2995a90ab0e62023-01-10WarningsExact identifier
application number: M020
Basin French Pear SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a39d91c-2dcf-71d6-e063-6394a90a54742022-02-10WarningsExact identifier
application number: M020
Basin Mexican Vanilla SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3a63d3-c7e0-bf03-e063-6394a90a16622022-02-10WarningsExact identifier
application number: M020
Basin Norwegian Berry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3c0aa0-7501-7ef0-e063-6294a90a9f942022-02-10WarningsExact identifier
application number: M020
Marcelle CC Cream Complete Correction Sunscreen Broad Spectrum SPF 35OCTINOXATE AND OXYBENZONEGroupe Marcelle Inc.c24ac3ad-b2e2-4381-bd80-a499da0e06702021-12-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-031-058064100310515 mL in 1 BOTTLE, DISPENSING (80641-031-05) 15 ml2026-03-20NoNoCurrent
80641-031-898064100318989 mL in 1 BOTTLE, DISPENSING (80641-031-89) 89 ml2026-02-02NoNoCurrent