FDA.reportPublic FDA data

Vacation SPF 50 Classic

Product NDC
80641-006
11-digit product format
806410006
Labeler code
80641
Product ID
80641-006_b319ee65-f0d1-40a8-b1d9-ceb3885d86ee
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Vacation INC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
2.8; 9.8; 4.9; 9.5 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 SPF 50 Classic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE2.8 g/100mL
HOMOSALATE9.8 g/100mL
OCTISALATE4.9 g/100mL
OCTOCRYLENE9.5 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
f268fb1c-d7c2-f2f9-e053-2995a90a9e22Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-006-01Vacation SPF 50 Classic100 mL in 1 TUBELOTION1005
80641-006-04Vacation SPF 50 Classic177 mL in 1 TUBELOTION1775
80641-006-08Vacation SPF 50 Classic1 in 1 BLISTER PACKLOTION15
80641-006-18Vacation SPF 50 Classic591 mL in 1 BOTTLE, PUMPLOTION5915
80641-006-80Vacation SPF 50 Classic30 mL in 1 TUBELOTION305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-006VACATION SPF 50 CLASSIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [VACATION INC.]4Current NDC, 5 package rows20250223_f268fb1c-d7c2-f2f9-e053-2995a90a9e22.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 278 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Sunscreen SPORT SPF 100AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWalmart Stores Inc.4fc58cea-082a-4535-9c51-8e7dedc15be32024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF 50 KIDS Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDEWAL-MART STORES INC81cb6b2e-1ca3-4a83-a8df-9bfee61e79af2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen SPF100 SPORT Broad SpectrumAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE OXYBENZONEWAL-MART STORES INC1ce4839b-f693-4653-8fe2-444df76eb83c2024-10-16WarningsExact identifier
application number: M020
Equate Sunscreen Mineral Based KIDS Broad Spectrum spf 50HOMOSALATE , OCTOCRYLENE, ZINC OXIDEWal-Mart Stores Inc0cdfc3a1-4bfa-474d-a4eb-4bfa1e628c892024-10-16WarningsExact identifier
application number: M020
EQUATE Sunscreen BABY Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTOCRYLENEWAL-MART STORES INCb2083cbd-ef19-4edc-9d7d-eca3452ee0ee2024-10-16WarningsExact identifier
application number: M020
Equate-Sunscreen Broad Spectrum SPF 50 ULTRAAVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEWal-Mart Stores Incbbe06f23-0d0f-43ff-9d1b-37a99d9d62062024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY SPF 50 SPORT SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.c8c1c904-12f5-48e0-e053-2a95a90a9f752024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEBIG LOTS STORES, INC.e717ec77-8beb-645a-e053-2a95a90ac11b2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 50 Ultra Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENEBIG LOTS STORES, INC.f0dcb5d8-a3e5-4334-e053-2995a90a535a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 30 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE,BIG LOTS STORES, INC.c8aede4f-3d84-63d1-e053-2a95a90afb1a2024-10-16WarningsExact identifier
application number: M020
Big Lots Soundbody SPF 70 Sun DefenseAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEBIG LOTS STORES, INC.db3ad809-d6c9-6c83-e053-2a95a90ac58b2024-10-16WarningsExact identifier
application number: M020
BIG LOTS SOUNDBODY KIDS SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBIG LOTS STORES, INC.e4b70fdb-7548-175c-e053-2995a90adfe62024-10-16WarningsExact identifier
application number: M020
BIOLUMIN-C HEAT AGING PROTECTOR SPF50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.38d0b78b-bd8e-4cb0-925a-19adff550c192024-10-16WarningsExact identifier
application number: M020
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
application number: M020
Mula Maldives SPF 30 Moisturizing SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEMula Maldives PVT LTDf9be092f-8d53-4bb2-8363-81c003da42d62024-10-15WarningsExact identifier
application number: M020
Kroger Invisible Sunscreen SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf71ee1cd-e075-9ee9-e053-6394a90a8f9f2024-10-15WarningsExact identifier
application number: M020
Kroger Sunscreen Oil SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76e12aa-9d98-5694-e053-6294a90a52562024-10-15WarningsExact identifier
application number: M020
Kroger Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATETHE KROGER COMPANYf0f350f4-b1b9-f4d3-e053-2995a90ac4592024-10-15WarningsExact identifier
application number: M020
Kroger Shimmer Sunscreen Hydrating SPF 40AVOBENZONE, OCTISALATE, OCTOCRYLENETHE KROGER COMPANYf76fe840-0da2-a903-e053-6294a90a05ee2024-10-15WarningsExact identifier
application number: M020
MINERAL BASED SPF 50 SUNSCREENZINC OXIDE, TITANIUM DIOXIDETHE KROGER COMPANYa4e6936d-a76c-e8fd-e053-2995a90a965f2024-10-15WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-006-0180641000601100 mL in 1 TUBE (80641-006-01) 100 ml2022-11-01NoNoCurrent
80641-006-0480641000604177 mL in 1 TUBE (80641-006-04) 177 ml2026-03-09NoNoCurrent
80641-006-08806410006081 TUBE in 1 BLISTER PACK (80641-006-08) / 177 mL in 1 TUBE (80641-006-04) 1 tube2026-03-09NoNoCurrent
80641-006-1880641000618591 mL in 1 BOTTLE, PUMP (80641-006-18) 591 ml2024-03-01NoNoCurrent
80641-006-808064100068030 mL in 1 TUBE (80641-006-80) 30 ml2022-11-01NoNoCurrent