FDA.reportPublic FDA data

Vacation SPF 50 Classic

Product NDC
80641-007
11-digit product format
806410007
Labeler code
80641
Product ID
80641-007_2ee97a94-d5a2-e05d-e063-6394a90a709b
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
SPRAY
Route
TOPICAL
Labeler
Vacation Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-01
Substance
HOMOSALATE; AVOBENZONE; OCTOCRYLENE; OCTISALATE
Active strength
8.8; 2.9; 8.6; 4.9 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE8.8 g/100mL
AVOBENZONE2.9 g/100mL
OCTOCRYLENE8.6 g/100mL
OCTISALATE4.9 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f2780cb5-063c-10d3-e053-2995a90a8576Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80641-007-01Vacation SPF 50 Classic177 mL in 1 CANSPRAY1773
80641-007-02Vacation SPF 50 Classic50 mL in 1 CANSPRAY503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80641-007VACATION SPF 50 CLASSIC (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [VACATION INC.]3Current NDC, 2 package rows20250226_f2780cb5-063c-10d3-e053-2995a90a8576.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 283 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Mineral SunscreenZINC OXIDEWALGREEN COMPANYd50787f1-0c50-d153-e053-2995a90add1e2024-10-14WarningsExact identifier
application number: M020
Walgreens SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYcfd7c1b0-cfc3-074f-e053-2995a90a5edb2024-10-14WarningsExact identifier
application number: M020
Well at Walgreens Mist Sheer Broad Spectrum Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEWALGREEN COMPANYdfc64c7b-ee59-62a3-e053-2995a90a14a12024-10-14WarningsExact identifier
application number: M020
WALGREENS SPORT CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYe4b84304-6053-0cfe-e053-2a95a90a124a2024-10-14WarningsExact identifier
application number: M020
Walgreens 50 Baby Mineral SunscreenZINC OXIDEWALGREEN COMPANYdbee6094-e105-6d14-e053-2995a90a15282024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF55 Sunscreen Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONcfd6dd4c-21f6-7cef-e053-2a95a90a50e22024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF50 Sport Sunscreen Lip Balm Reef-Conscious FormulaAVOBENZONE, HOMOSALATE, OCTOCRYLENETARGET CORPORATIONf8c100bd-9230-813b-e053-6294a90ae0062024-10-14WarningsExact identifier
application number: M020
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious FormulaTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONcfd735d2-df3a-5ed0-e053-2995a90a9f262024-10-14WarningsExact identifier
application number: M020
Target Goodfellow and Co SPF 30 Face Scent No. 05 Kelp and Sea MineralAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONf98ee294-3ca5-18bd-e053-6394a90a9aa52024-10-14WarningsExact identifier
application number: M020
Target Up and Up Oil Free Facial Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONf9027e42-017a-07fd-e053-6294a90ab9162024-10-14WarningsExact identifier
application number: M020
Target Up and Up SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETARGET CORPORATIONf99028fa-a17e-4a84-e053-6294a90a927f2024-10-14WarningsExact identifier
application number: M020
Up and Up Illuminating Daily Moisturizer with Sunscreen Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATETARGET CORPORATION9407a4a9-8a72-6a01-e053-2a95a90a231d2024-10-14WarningsExact identifier
application number: M020
Target Up and Up Morning Facial Moisturizing with Sunscreen Broad Spectrum SPF 30HOMOSALATE, OCTOCRYLENE, ZINC OXIDETARGET CORPORATIONf9b66e3e-5493-9ea4-e053-6294a90a60632024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a6296612-184c-6b3c-e053-2a95a90a34b92024-10-14WarningsExact identifier
application number: M020
OPEN NATURE SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6020d2f-55c4-adfc-e053-2a95a90ad2382024-10-14WarningsExact identifier
application number: M020
OPEN NATURE CHILDREN SPF 50 MINERAL SUNSCREENZINC OXIDESAFEWAY, INC.a6044f0f-eb86-684d-e053-2995a90a09212024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a62848fb-7016-3457-e053-2a95a90aa0f12024-10-14WarningsExact identifier
application number: M020
Safeway Signature Care Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENESafeway, Inc.c6a0ae3e-d68a-b838-e053-2a95a90a77f72024-10-14WarningsExact identifier
application number: M020
SIGNATURE CARE SPORT SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESAFEWAY, INC.a628ff71-463d-4d39-e053-2995a90a7a422024-10-14WarningsExact identifier
application number: M020
CVS Health SPF 70 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONESafeway, Inc.c5106c63-af51-c169-e053-2a95a90afef22024-10-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80641-007-0180641000701177 mL in 1 CAN (80641-007-01) 177 ml2022-12-01NoNoCurrent
80641-007-028064100070250 mL in 1 CAN (80641-007-02) 50 ml2025-02-24NoNoCurrent