FDA.reportPublic FDA data

LUXURY SUN RITUAL

Product NDC
82404-101
11-digit product format
824040101
Labeler code
82404
Product ID
82404-101_47d86fa0-0c4d-3b34-e063-6294a90a1eee
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
JANE STREET LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
ZINC OXIDE
Active strength
10 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
LUXURY SUN RITUAL
Brand name suffix
PORE SMOOTHING SPF 30 SUNSCREEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbdd3e6a-f09d-90cf-e053-2a95a90a98a0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82404-101-11LUXURY SUN RITUALPORE SMOOTHING SPF 30 SUNSCREEN50 mL in 1 TUBELOTION504
82404-101-12LUXURY SUN RITUALPORE SMOOTHING SPF 30 SUNSCREEN1 in 1 BOXLOTION14
82404-101-13LUXURY SUN RITUALPORE SMOOTHING SPF 30 SUNSCREEN3 mL in 1 TUBELOTION34
82404-101-14LUXURY SUN RITUALPORE SMOOTHING SPF 30 SUNSCREEN25 mL in 1 TUBELOTION254
82404-101-15LUXURY SUN RITUALPORE SMOOTHING SPF 30 SUNSCREEN1 in 1 BOXLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82404-101LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN (ZINC OXIDE) LOTION [JANE STREET LLC]3Current NDC, Legacy NDC, 5 package rows20231207_dbdd3e6a-f09d-90cf-e053-2a95a90a98a0.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 258 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Lip Balm SPF-15ZINC OXIDETUBBY TODD4d938672-5302-4e47-a582-c3e6467008cb2024-12-18WarningsExact identifier
application number: M020
SaltyFace Daily Sun Shield Mineral Sunscreen For Face SPF 30ZINC OXIDESaltyface Natural Incf0cc7ce9-81b3-439f-b5ee-96138de54e782024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 JasmineTITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasole999d752-6c00-459e-b6c3-d264c330597d2024-12-18WarningsExact identifier
application number: M020
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
application number: M020
Costa Sea Mineral Sunscreen SPF 50ZINC OXIDECOSTA SEA INC841e1b3d-dbbc-4bb0-886a-fb2d077ae7392024-12-18WarningsExact identifier
application number: M020
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
application number: M020
Softlips Vanilla, Watermelon, CherryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company2235d029-157e-4a30-be90-605e6bc143fd2024-12-17WarningsExact identifier
application number: M020
Softlips Salted Caramel, Candy Apple, Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company42cf4623-0eb8-455a-b374-8e17e9336b922024-12-17WarningsExact identifier
application number: M020
Softlips Peppermint Mocha, Apple Chai Cider, Orange CranberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company0338c078-695d-4d4e-9e90-5a8a98d495242024-12-17WarningsExact identifier
application number: M020
Softlips Pearl Plus VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company107bcaa9-4347-4979-be44-35183a9ee67e2024-12-17WarningsExact identifier
application number: M020
Softlips RaspberryDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyd18b4c19-0365-44ec-bea8-4328e537e0d82024-12-17WarningsExact identifier
application number: M020
Softlips WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company03062f13-270d-49cf-8939-2349f12e9cba2024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Companyf733747a-ad1a-4222-baf1-69dcd90a33502024-12-17WarningsExact identifier
application number: M020
Softlips Vanilla WatermelonDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1fbe85a2-4cd7-45bd-85a2-83bbf75c5f972024-12-17WarningsExact identifier
application number: M020
Softlips Marshmallow GhostDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8d55141d-5d6f-4eec-87dc-d3c808cf7a6a2024-12-17WarningsExact identifier
application number: M020
Softlips PearlOCTINOXATE, OCTISALATEThe Mentholatum Company43e175b4-7a48-431e-bf27-9ce7dee53f5e2024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Watermelon BlackberryDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companye1213808-4dad-4fd0-871a-04bba094a3cc2024-12-17WarningsExact identifier
application number: M020
Softlips PeppermintDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company1a0062f1-fcfc-4d6a-8274-2ebbc5fbdb272024-12-17WarningsExact identifier
application number: M020
Softlips Oasis Pineapple Coconut, Peach Mango, Strawberry KiwiDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Company7c8a4921-ae45-47fb-a64e-c72b1a386d0d2024-12-17WarningsExact identifier
application number: M020
Mentholatum Medicated Lip Balm CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company6edb132d-bb67-4e6c-8e18-db0305073a712024-12-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82404-101-118240401011150 mL in 1 TUBE50 mlHistorical
82404-101-12824040101121 TUBE in 1 BOX (82404-101-12) / 50 mL in 1 TUBE (82404-101-11) 1 tube2022-05-010000-00-00NoNoCurrent
82404-101-13824040101133 mL in 1 TUBE (82404-101-13) 3 ml2022-05-010000-00-00YesNoCurrent
82404-101-148240401011425 mL in 1 TUBE25 mlHistorical
82404-101-15824040101151 TUBE in 1 BOX (82404-101-15) / 25 mL in 1 TUBE (82404-101-14) 1 tube2022-12-010000-00-00NoNoCurrent