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 270 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands, LLC9751a700-5d51-357b-e053-2a95a90af66c2024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Ultra Face SPF30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCdc757b03-7e7d-b362-e053-2a95a90a84462024-10-27WarningsExact identifier
application number: M020
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe5f9d56d-a80e-221c-e053-2a95a90aae922024-10-27WarningsExact identifier
application number: M020
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe53509bf-6bb7-2db7-e053-2a95a90aae182024-10-27WarningsExact identifier
application number: M020
Banana Boat Sport Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc79790f-e2bc-5414-e053-2a95a90a9e7a2024-10-27WarningsExact identifier
application number: M020
TiZO Mineral Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDfd6d0080-0bef-4e7e-8ca5-b859639efd0c2024-10-25WarningsExact identifier
application number: M020
Alumier MD Post Procedure Kit with HydrocortisoneTITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONEAlumier Labs2551d748-c3d6-cd18-e063-6294a90adab62024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Stick Non-Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDe7044f18-992a-4f60-9a2b-f11ed06db09b2024-10-25WarningsExact identifier
application number: M020
CoTZ Lip BalmTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD479a7d82-a068-4c2e-b50b-555c40e13e372024-10-25WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.e17a8c35-2d49-4c99-b154-ea673c14753e2024-10-25WarningsExact identifier
application number: M020
IPKN Moist and Firm Beauty Balm Light MediumTITANIUM DIOXIDEInel Cosmetics Co., Ltd.1af6184e-3dc4-4eb3-8d51-aca7244734512024-10-25WarningsExact identifier
application number: M020
IPKN Moist and Firm Beauty Balm LightTITANIUM DIOXIDEInel Cosmetics Co., Ltd.77d77838-aa13-4939-a1a0-50189fbb3fe02024-10-25WarningsExact identifier
application number: M020
Dove Men plus Care Hydrate FaceAVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENECONOPCO Inc. d/b/a Unileverafe75aff-c056-eaf7-e053-2a95a90af71b2024-10-24WarningsExact identifier
application number: M020
Cancer Council Mineral Fluid SPF50ZINC OXIDEVitality US Co.1638f8a4-a2da-4e1f-e063-6294a90a03d92024-10-24WarningsExact identifier
application number: M020
Marlowe SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMarlowe Holdings, LLCf94bd91a-f0ab-680c-e053-6394a90ac8552024-10-23WarningsExact identifier
application number: M020
Vacation Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.2526eadf-4b55-ff81-e063-6394a90a3ba72024-10-23WarningsExact identifier
application number: M020
Tenacious ErgodyneKREWD CLEAR SPF 50 CONTINUOUS SPRAYTenacious Holdings, Inc.55d99d0a-dc7f-4915-b7c1-f999c8b36e0d2024-10-23WarningsExact 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