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 323 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMAKA Broad Spectrum SPF-42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS32b892fd-c68f-4670-bbaa-0b3de57128492023-11-11WarningsExact identifier
application number: M020
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDESKINMETICS INC4a719986-d1d0-4156-b803-04004b7215042023-11-11WarningsExact identifier
application number: M020
DERMAKA Broad Spectrum SPF-42 Sunscreen UntintedTITANIUM DIOXIDE, ZINC OXIDEDERMAKA SKIN PRODUCTS9aa24e1f-e338-4947-a437-554fb6b227a22023-11-11WarningsExact identifier
application number: M020
TIGER BABY Baby Sunscreen SPF-50ZINC OXIDEBRICKELL BRANDS LLCf2aa0e03-e8b6-42d0-8fa0-2e96ca486b5c2023-11-11WarningsExact identifier
application number: M020
Brickell Mens Products Daily Defense Face Moisturizer SPF-20OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLCa61e20e4-d5c9-4dc4-a18a-cc88b358d15c2023-11-11WarningsExact identifier
application number: M020
EIGHT SAINTS Chase The Sun SPF-30OCTOCRYLENE, OCTISALATE, ZINC OXIDEBRICKELL BRANDS LLC9b19b2b4-d8b9-415d-a217-4a5ef3d75a8c2023-11-11WarningsExact identifier
application number: M020
LUCKY 13s ALL NATURAL TATTOO SUNSCREEN SPF-30ZINC OXIDESALES BRAIN HOLDINGS LLCec06bc4b-90d6-4b41-9086-f57737a34d912023-11-11WarningsExact identifier
application number: M020
TRENDY JOHN SPF-32 Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETRENDY JOHN LLC80dccecb-fbb3-4af6-9cb4-6acea733e9962023-11-11WarningsExact identifier
application number: M020
CARIBBEAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC19117321-c37b-4b37-9bd6-7c5c973e2f312023-11-11WarningsExact identifier
application number: M020
MIAMI BEACH BUM Blocked SPF-30 SunscreenZINC OXIDEMIAMI BEACH BUM669443a1-7b54-454f-b22f-8cfa9df38bbb2023-11-11WarningsExact identifier
application number: M020
STRYX Daily Moisturizer SPF-30OCTISALATE, ENSULIZOLESTRYX MEN, INC.2bac4348-5b5d-41cc-893e-b9d5c1215ab02023-11-11WarningsExact identifier
application number: M020
SIMPLI DAY All In One SmartCream SPF 42ZINC OXIDE, OCTISALATE, OCTOCRYLENE, ENSULIZOLESIMPLI SKIN MD LLCe5aab0ec-eda2-4073-998a-966202dc22332023-11-11WarningsExact identifier
application number: M020
HAWAIIAN SOL Natural Sunscreen SPF-30ZINC OXIDECaribbean Sol International, LLC3c43fe36-2c24-4859-a262-8af4d3420e472023-11-11WarningsExact identifier
application number: M020
JOYSPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC3ca50033-5bcb-4a6d-8aba-a797c5b8d0e92023-11-11WarningsExact identifier
application number: M020
TANCEUTICALS SPF DROPS Broad Spectrum SPF-30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETANCEUTICALS, LLC8640b971-7c99-4c8f-ac5c-ecdd88b99fe02023-11-11WarningsExact identifier
application number: M020
PROTEKT SPF-50 Sheer Mineral SunscreenZINC OXIDEProtekt Products, Inc.806b4e40-0e02-424b-80e7-026a211b4dfe2023-11-11WarningsExact identifier
application number: M020
KOVR All-Natural SPF-30 Moisturizing Sunscreen for WomenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INC0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed2023-11-11WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPF 50ZINC OXIDEProven Skincarebb921e91-9faf-4210-9091-ab511af9012a2023-11-10WarningsExact identifier
application number: M020
Personalized Day Moisturizer with SPFZINC OXIDEProven Skincaref4d682bc-825f-494c-8528-3d328dc639942023-11-10WarningsExact identifier
application number: M020
Ultra Replenishing Sunscreen SPF 40HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXYIDE CREAMCosMedical Technologies, LLC92ad5d7a-9adb-7d55-e053-2995a90a80e72023-11-10WarningsExact 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