FDA.reportPublic FDA data

Mineral Lip Balm

Product NDC
69949-559
11-digit product format
699490559
Labeler code
69949
Product ID
69949-559_ed310459-adfa-43b0-b673-532a6b5f515b
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
STICK
Route
TOPICAL
Labeler
Synchronicity Spa, Inc. DBA Suntegrity
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-15
Substance
ZINC OXIDE
Active strength
.34 g/4.25g
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
Mineral Lip Balm
Brand name suffix
Pineapple
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE.34 g/4.25g

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
667714f6-38bc-4c94-aacc-24b46e8e59fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69949-559-01Mineral Lip Balm Pineapple4.25 g in 1 TUBESTICK4.251

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 106 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC85f3dd47-4f1f-4fa3-a171-4f4b7707191c2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4e5764f3-9d9e-460b-ab1e-36f280281dec2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUMTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe700dc6e-e7ae-47ee-9974-430bfd045b4f2025-12-19WarningsExact identifier
application number: M020
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCc7924d60-03fb-4a4d-b718-e324f6f1f65f2025-12-19WarningsExact identifier
application number: M020
THE GOLDEN GUARD Browning Radiance Gel Suncare for BodyAVOBENZONE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.4654c417-faa3-23c6-e063-6394a90a2b5a2025-12-19WarningsExact identifier
application number: M020
THE MINERAL MELT Invisible Mineral Suncare for FaceTITANIUM DIOXIDE, ZINC OXIDEDune Suncare, Inc.46557319-7546-e712-e063-6394a90a3cfe2025-12-19WarningsExact identifier
application number: M020
Sand Cloud Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff477199-9b01-fc90-e053-6294a90a51022025-12-19WarningsExact identifier
application number: M020
Sand Cloud Mineral Sunscreen For FaceTITANIUM DIOXIDE AND ZINC OXIDESand Cloud Holdings, LLCff2346c6-d911-87b3-e053-6394a90ac6f82025-12-19WarningsExact identifier
application number: M020
Radiant Defense Perfecting Liquid Broad Spectrum SPF 30 - ShellTITANIUM DIOXIDE, ZINC OXIDERodan & Fields12c63195-8707-4df0-a4d3-6f31c543db7a2025-12-19WarningsExact identifier
application number: M020
EltaMD UV SPF35OCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc3029d6ed-a60b-4789-a567-d09b12d76bf42025-12-19WarningsExact identifier
application number: M020
OUHOE Universal Colored MoisturizerTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4634fdcd-6f0e-25ca-e063-6294a90a196e2025-12-18WarningsExact identifier
application number: M020
SUNSCREEN SPRAY150mLZINC OXIDE 12%, TITANIUM DIOXIDE 6%, HOMOSALATE 14%, OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4635f90a-bbc9-0676-e063-6394a90a9f352025-12-18WarningsExact identifier
application number: M020
Sunscreen StickHOMOSALATE 15%, OCTISALLATE 5%, ENSULIZOLE 4%Foshan Sugar Max Cosmetics CO.,Ltd4637503c-46dc-68de-e063-6394a90abdc72025-12-18WarningsExact identifier
application number: M020
HAWAIIAN TROPIC SUNSCREEN SHEER TOUCH SPF 70AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLCe78c9ae0-c2ef-12ce-e053-2995a90abf1c2025-12-18WarningsExact identifier
application number: M020
NARS PURE RADIANT TINTED MOISTURIZER CuzcoOCTINOXATE, TITANIUM DIOXIDENARS Cosmetics5bb5d035-16d9-4843-b9aa-d30730c885082025-12-18WarningsExact identifier
application number: M020
Olay Regenerist Micro-Sculpting Hydrating Moisturizer Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company248be719-edff-f40d-e063-6394a90a4ef62025-12-18WarningsExact identifier
application number: M020
Olay Complete UV 365 Daily Moisturizer Normal Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company59187729-c166-58fe-e053-2991aa0abe472025-12-18WarningsExact identifier
application number: M020
GM Collin SPF 25 UVA - UVB Urban Protection Veil SunscreenZINC OXIDE AND TITANIUM DIOXIDELaboratoires Dermo-Cosmetik Inc.4f0d44ca-09f0-4feb-b78c-77d83e75d4e22025-12-18WarningsExact identifier
application number: M020
Olay Complete UV365 Daily Moisturizer with Sunscreen Broad Spectrum SPF 30 SensitiveOCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEThe Procter & Gamble Manufacturing Company60a304b1-eee5-408b-e053-2a91aa0a0a082025-12-18WarningsExact identifier
application number: M020
THE BOD GUARD Invisible Gel Sunscreen for BodyAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEDune Suncare, Inc.463fa1ef-d40d-d818-e063-6294a90a5e612025-12-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69949-559-01699490559014.25 g in 1 TUBE (69949-559-01) 4.25 g2025-07-15NoNoCurrent