FDA.reportPublic FDA data

TINTED MINERAL SUNSCREEN

Manufacturer
Buttah Enterprises, LLC.
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:04

Label at a glance#

ProductTINTED MINERAL SUNSCREEN SPF-30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD-SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:      LIMIT TIME IN THE SUN,...

Storage and handling

CALL TOLL FREE:  1-800-428-8824

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 2.5%

ZINC OXIDE 6%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGE OR BROKEN SKIN.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY LIBERALLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
  • SUN PROTECTION MEASURES: SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD-SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
  •      LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM.
  •      WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.
  •      CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Caprylic/Capric Triglyceride, Cyclopentasiloxane, Propanediol, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, PEG-100 Stearate, Glyceryl STearate, Cetyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Cyclohexasiloxane, Sucrose Cocoate, Citric Acid, Sodium Citrate, Sodium PCA, Glyceryl Isostearate, Alumina, Caprylyl Methicone, Polyhydroxystearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Dimethicone, Chlorphenesin, Iron Oxides, Allantoin, Xanthan Gum, Camellia Oleifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativus (Cucumber) Fruit Extract, Glyceryl Undecylenate, Panthenol, Phytic Acid, Sodium Hyaluronate.

STORAGE AND HANDLING SECTION

CALL TOLL FREE:  1-800-428-8824

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

  • call toll free:  1-833-428-8824

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0-LBL_Buttah_Tinted Mineral Sunscreen SPF30_2oz0-LBL_Buttah_Tinted Mineral Sunscreen SPF30_2oz

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82069-101TINTED MINERAL SUNSCREEN SPF-30 (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [BUTTAH ENTERPRISES, LLC.]4Legacy NDC20231106_a78ebc0c-58f0-4a34-bde2-c4c014f39f61.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82069-10182069-101-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PROPANEDIOL5965N8W85TIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETYL ALCOHOL936JST6JCNIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
CYCLOMETHICONE 6XHK3U310BAIACT
SUCROSE COCOATE3H18P0UK73IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
GLYCERYL ISOSTEARATEHYE7O27HAOIACT
ALUMINUM OXIDELMI26O6933IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
DIMETHICONE 100RO266O364UIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
CHLORPHENESINI670DAL4SZIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MATRICARIA RECUTITA FLOWERING TOP3VNC7T6Z02IACT
CUCUMBERYY7C30VXJTIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
PANTHENOLWV9CM0O67ZIACT
FYTIC ACID7IGF0S7R8IIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4345b0d2-22a5-22fd-e063-6394a90afcc5a78ebc0c-58f0-4a34-bde2-c4c014f39f612025-11-10WarningsExact identifier
spl set id: a78ebc0c-58f0-4a34-bde2-c4c014f39f61

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.