FDA.reportPublic FDA data

VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

Product NDC
80641-001
11-digit product format
806410001
Labeler code
80641
Product ID
80641-001_47224083-a029-4253-9660-b228c66263ff
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
2021-04-15
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
25; 100; 50; 80 mg/mL; mg/mL; mg/mL; mg/mL
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 CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE25 mg/mL
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE80 mg/mL

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
c7794831-52d1-4d80-936d-44af18ae0472Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
80641-001-012024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-022024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-032024-03-04VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-012024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-022024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN
80641-001-032024-01-30VACATION ® CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-001-01VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN100 mL in 1 TUBELOTION1008
80641-001-02VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN30 mL in 1 TUBELOTION308
80641-001-03VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN7 mL in 1 PACKETLOTION78
80641-001-04VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN177 mL in 1 TUBELOTION1778
80641-001-04VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN2 in 1 KITLOTION28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-001VACATION CLASSIC BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [VACATION INC.]5Current NDC, Legacy NDC, 5 package rows20250109_c7794831-52d1-4d80-936d-44af18ae0472.zip

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 216 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LBEL FOREVER MATTE LONGWEAR AND CONTROL FOUNDATION 72H SPF 15 CHAMPAGNE 170NOCTINOXATE, ZINC OXIDEBEL STAR S.A.338c2c66-497a-f7d1-e063-6294a90a77892025-04-24WarningsExact identifier
application number: M020
The Ordinary UV Filters SPF 45 SerumHOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATEDeciem10cde253-26ee-b97d-e063-6394a90a83022025-04-23WarningsExact identifier
application number: M020
BareBack sunscreen SPF50 infused with Hyaluronic acid and vitamin CZINC OXIDEVeganicSKN3123aab6-0407-19e5-e063-6394a90a5bd82025-04-23WarningsExact identifier
application number: M020
Sephora Daily Sunscreen Cream Broad Spectrum SPF 30ZINC OXIDES+b49e043b-8164-421c-a02b-3dab0be1454d2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Sports CreamZINC OXIDEYAYA ORGANICS L.L.C.9eabf1f8-698b-4fa8-98d3-3696c35b044c2025-04-22WarningsExact identifier
application number: M020
YAYA Organics SPF-50 Baby Kids Mineral SunscreenZINC OXIDEYAYA ORGANICS L.L.C.3275303d-a448-4fb4-bdce-6442823f89962025-04-22WarningsExact identifier
application number: M020
Oathology Inzincable Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, ZINC OXIDESKINOATH LLCd245dfca-9e32-4e71-9df8-58fff84ef6a92025-04-22WarningsExact identifier
application number: M020
Back9ine Skincare Pure Invisible Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBack 9ine Skincare, LLC974ede40-cfb5-4612-b168-5d42dd137f632025-04-22WarningsExact identifier
application number: M020
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
application number: M020
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLCc914c4cd-99a2-4d9f-8f04-8af2ace3c3452025-04-18WarningsExact identifier
application number: M020
Charlis Neutral Tinted Face Moisturizer Mineral Sunscreen SPF 25ZINC OXIDECHARLIS LLC330f7470-0d53-7361-e063-6394a90a5d592025-04-18WarningsExact identifier
application number: M020
Chardonnay Lip OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc1318a429-d382-f5b8-e063-6394a90a3bd42025-04-18WarningsExact identifier
application number: M020
Shimmer OilAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEVacation Inc.131c63ba-57fc-9ce8-e063-6294a90acd922025-04-18WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC055431a6-e9e0-99b4-e063-6394a90acb112025-04-17WarningsExact identifier
application number: M020
SILKEN pore perfecting sunscreen broad spectrum SPF 35OCTISALATE, ZINC OXIDETATCHA INC.251566a1-0e21-4030-9d4e-52c4a8bd33302025-04-16WarningsExact identifier
application number: M020
Dermatone SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDermatone Labs LLC32e5bddf-a0b5-c511-e063-6294a90aaf662025-04-16WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF 30 Cool MintAVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 9%USRX3271ab14-3bf5-a24f-e063-6294a90a59bc2025-04-16WarningsExact identifier
application number: M020
goodal GREEN TANGERINE VITA C DARK SPOT UV DEFENSE SUNSCREEN SPF50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONECLIO COSMETICS Co., Ltd.77a0d190-f558-474b-89d2-c79b37c50c0d2025-04-16WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Touch of Tan Zinc Only - REFILLZINC OXIDESPF Ventures, LLC32ccb93a-50cf-f436-e063-6294a90a24922025-04-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80641-001-0180641000101100 mL in 1 TUBE (80641-001-01) 100 ml2022-04-060000-00-00NoNoCurrent
80641-001-028064100010230 mL in 1 TUBE (80641-001-02) 30 ml2022-04-060000-00-00NoNoCurrent
80641-001-03806410001037 mL in 1 PACKET (80641-001-03) 7 ml2022-04-060000-00-00NoNoCurrent
80641-001-04806410001042 TUBE in 1 KIT (80641-001-04) / 177 mL in 1 TUBE2 tube2024-03-01NoNoCurrent