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 194 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olay Complete Hydrating with Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company3ccd2703-c410-74b7-e063-6294a90a7f882025-08-20WarningsExact identifier
application number: M020
SEYEZINC OXIDE AND TITANIUM DIOXIDE CREAMGuangzhou Seye Biomedical Technology Co., Ltd.3cce91b1-311b-4c95-e063-6294a90a2d7a2025-08-20WarningsExact identifier
application number: M020
Sun Bum Day Tripper - SPF 30 Moisturizing Sunscreen 3 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3ccfb90a-5976-4b38-e063-6294a90a123a2025-08-20WarningsExact identifier
application number: M020
Sun Bum Day Tripper - SPF 30 Sunscreen Lip Balm (Coconut) 0.15 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cd3ce69-becc-41b7-e063-6394a90a27822025-08-20WarningsExact identifier
application number: M020
Lip Therapy Soothe and Protect Lip Treatment Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEObagi Cosmeceuticals LLC4838679b-f510-440b-8670-a10c05ebed9b2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 NewZINC OXIDESun Bum, LLC3b8e1d73-b023-cfbd-e063-6294a90ae29d2025-08-19WarningsExact identifier
application number: M020
Olay Total Effects Moisturizer with Sunscreen Broad Spectrum SPF 15 Fragrance-FreeAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company8de31db2-46cf-7178-e053-2995a90a50242025-08-19WarningsExact identifier
application number: M020
Lip Balm - Variety Pack (Target) - Banana (4)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3cbcae23-9b38-edaa-e063-6294a90a2e8f2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Lip Balm 30ZINC OXIDESun Bum, LLC3cbeb4ce-6d7c-387c-e063-6394a90af7902025-08-19WarningsExact identifier
application number: M020
Olay Total Effects Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEThe Procter & Gamble Manufacturing Company8de52cb2-b4d2-1e0d-e053-2995a90a5aca2025-08-19WarningsExact identifier
application number: M020
Sun Bum 30 Mineral Sunscreen Lip BalmZINC OXIDESun Bum, LLC3cbfba65-5702-50b5-e063-6394a90a409d2025-08-19WarningsExact identifier
application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50ZINC OXIDESun Bum, LLC324e8ddb-89d2-08ca-e063-6294a90ab6c12025-08-19WarningsExact identifier
application number: M020
Sun Bum 70 Premium SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b02811d-dc66-fc6f-e063-6294a90aefc82025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b058b74-27d0-8f8a-e063-6294a90aa02c2025-08-18WarningsExact identifier
application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit ExtractZINC OXIDESupergoop LLC3ca7e1ed-7cc7-76b0-e063-6394a90ade932025-08-18WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZZINC OXIDESun Bum, LLC3b91a7e3-ce52-6aa0-e063-6394a90a15e72025-08-18WarningsExact identifier
application number: M020
CoTZ KidsZINC OXIDEFallien Cosmeceuticals, LTD.3ca8742f-67cb-a25c-e063-6394a90a46382025-08-18WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b154009-9c6f-eadf-e063-6394a90ae4242025-08-18WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b162348-0222-490e-e063-6394a90ad4942025-08-18WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3b169860-66bc-dd02-e063-6294a90a79742025-08-18WarningsExact 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