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 267 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Sunly Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d8551c6-2efe-11a8-e063-6294a90aed012024-12-01WarningsExact identifier
application number: M020
ATTITUDE Oatmeal Sensitive Natural Mineral Sunscreen Face Stick Unscented SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d958343-31e3-0b7a-e063-6294a90a424a2024-12-01WarningsExact identifier
application number: M020
Attitude Kids mineral sunscreen unscented SPF 30ZINC OXIDE9055-7588 Qubec Inc. DBA Attitudec2461e22-1518-4f9e-ad8c-951784ef8b5f2024-12-01WarningsExact identifier
application number: M020
BIO SPECTRA ATTITUDEZINC OXIDE9055-7588 Quebec Inc. DBA Attitude954713fe-c84c-41b4-913d-3507ed91e55d2024-12-01WarningsExact identifier
application number: M020
CAUDALIE Daily Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDECaudalie USA, Inc.150e3bf3-7b05-e611-e063-6294a90a09322024-11-29WarningsExact identifier
application number: M020
CLEARING DEFENSE SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.2cb559d3-dd79-4951-ad38-190fd4dd7c402024-11-27WarningsExact identifier
application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC1ccde0bc-08aa-8a25-e063-6394a90a27622024-11-25WarningsExact identifier
application number: M020
Girlyish Skincare Mineral Sunscreen SPF 30ZINC OXIDERise Skincare LLC137ba0be-91ce-4bd0-9713-57b1693597502024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 9NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior95d657e5-cf89-48dd-a12e-f9664b131eb92024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior33f42840-92f8-4fa1-86e9-ec0a06d637de2024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 6WOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior20785934-e534-4ea5-8c15-f9669b0421532024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 7NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diore4464601-a9ec-413b-a883-9efe61f2f5b22024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 8NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5e7c879c-1e5c-4614-bec1-d363978c3b0d2024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 4NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5c1f1f09-19fb-4ceb-bb6d-22d51b5733a82024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 5WOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc8a48759-efac-47ac-972a-c994b6774e202024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 1NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior793c18e5-4363-45b0-a184-0b6c69a91b2c2024-11-25WarningsExact identifier
application number: M020
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2NOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8a542b3c-c3c0-465a-9b24-6a62016656f32024-11-25WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK MATTE FINISH BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CLARO 110COCTINOXATE, ZINC OXIDEBEL STAR S A27c30645-dcef-bc31-e063-6394a90a13682024-11-25WarningsExact identifier
application number: M020
SKIN LONG-WEAR WEIGHTLESS FOUNDATION BROAD SPECTRUM SPF 15OCTINOXATE AND TITANIUM DIOXIDEBobbi Brown Professional Cosmetics Inc.b669c36d-4c94-455d-8534-9c3bb024d6682024-11-25WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands, LLC8a1eefa6-619e-5d02-e053-2995a90a3d752024-11-25WarningsExact 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