FDA.reportPublic FDA data

HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD

Product NDC
10596-002
11-digit product format
105960002
Labeler code
10596
Product ID
10596-002_47ac59f3-a2c0-65e4-e063-6294a90a27c7
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
STICK
Route
TOPICAL
Labeler
Kao USA Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-12
Substance
ZINC OXIDE
Active strength
229.5 mg/g
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
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE229.5 mg/g

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
26cf1320-aae5-2ea0-e063-6394a90a3be2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-002-01HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD1 in 1 CARTONSTICK12
10596-002-01HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD5.2 g in 1 TUBESTICK5.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10596-002HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUD (ZINC OXIDE) STICK [KAO USA INC.]1Current NDC, 2 package rows20241115_26cf1320-aae5-2ea0-e063-6394a90a3be2.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 99 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUTURIST SKIN TINT SERUMOCTINOXATE,OCTISALATE,ZINC OXIDEESTEE LAUDER INCea21e5a5-69d6-2de4-e053-2995a90a93b42025-12-31WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact identifier
application number: M020
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
application number: M020
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEFormula 7venz L.L.C.e8e350e7-9225-4802-89a6-66e45ebc442d2025-12-31WarningsExact identifier
application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35Kinfield, Inc.0710db9f-fe91-4b98-a337-5fde33d98a9d2025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.1030c5a4-3067-48e6-a21c-0d327ef434d02025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.612c5730-c3b4-486e-8ce9-8a861f676fa82025-12-30WarningsExact identifier
application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum SunscreenKINFIELD LIPLOCK SUNSCREENKinfield, Inc.477aa1a2-c893-4750-84da-e5afe7ccd45b2025-12-30WarningsExact identifier
application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.cbdfd0ae-514b-4b53-98ad-4270163bd0df2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDECLINIQUE LABORATORIES LLC2397aca5-bf0a-619d-e063-6394a90a7ab92025-12-30WarningsExact identifier
application number: M020
Resource Essentials Sun Protection Mineral SPF 3014% ZINC OXIDESkinresource.md, L.L.C.45b486cf-28ee-6392-e063-6394a90affb02025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47313277-8884-70b5-e063-6394a90a5fca2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47320858-0aea-6ee9-e063-6294a90a9fa92025-12-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10596-002-01105960002011 TUBE in 1 CARTON (10596-002-01) / 5.2 g in 1 TUBE1 tube2024-11-12NoNoCurrent