FDA.reportPublic FDA data

buttah Tinted Mineral Sunscreen

Product NDC
82069-102
11-digit product format
820690102
Labeler code
82069
Product ID
82069-102_43458152-0776-dd9c-e063-6394a90a6140
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE, ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Buttah Enterprises, LLC.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-13
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
6; 2.5 g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
buttah Tinted Mineral Sunscreen
Brand name suffix
SPF-30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE6 g/100mL
TITANIUM DIOXIDE2.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43458152-0775-dd9c-e063-6394a90a6140Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82069-102-12buttah Tinted Mineral SunscreenSPF-3060 mL in 1 TUBELOTION601

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 48 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simple Mineral Sunscreen SPF 50ZINC OXIDESimple Sunscreen LLCc38cb4fa-8b8d-4c2d-9c32-301e120db1a12026-04-06WarningsExact identifier
application number: M020
Badger SPF 50 Adventure Sport Mineral Sunscreen CreamZINC OXIDEW.S. Badger Company, Inc.2a96c423-f4ad-0f07-e063-6394a90a39f82026-04-06WarningsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 55AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC03fce792-bcbb-4848-bc87-8913ecbe07862026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC8937705d-b745-4b8c-bf9b-89e64a1e52b12026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab6773f-00e1-897a-e063-6294a90ab0b82026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEGuthy-Renker LLCeb1a9b67-b9e2-41f8-bc6d-df94b6a33ab82026-04-06WarningsExact identifier
application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUMHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENETIRTIR USA Inc.4ec04105-e54f-a82e-e063-6394a90a6c5a2026-04-05WarningsExact identifier
application number: M020
PRVWORA Ultra Defense SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECellarkbio Inc.50cf1d88-3e7e-47b7-816a-3d579bde0a6a2026-04-04WarningsExact identifier
application number: M020
EltaMD UV Shield SPF45ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.7c49f971-d425-4be9-a665-5cd218b7f9452026-04-03WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
application number: M020
Vacation SPF 30 ClassicSprayAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.da43d71d-733b-5700-e053-2a95a90a5dca2026-04-03WarningsExact identifier
application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30ZINC OXIDEAllure Labs4e93e64a-97ab-e0a5-e063-6294a90ad9502026-04-03WarningsExact identifier
application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
application number: M020
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
application number: M020
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
application number: M020
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTEDZINC OXIDEFallien Cosmeceuticals, LTD4e7c4702-5707-6c3e-e063-6394a90a05fd2026-04-02WarningsExact identifier
application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light MediumZINC OXIDEIlia, Inc.4e7cc73c-d6c9-ecb0-e063-6394a90a922c2026-04-02WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82069-102-128206901021260 mL in 1 TUBE (82069-102-12) 60 ml2021-07-14NoNoCurrent