FDA.reportPublic FDA data

Mineral Mist

Manufacturer
TUBBY TODD
Effective date
2025-12-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:20:33

Label at a glance#

ProductMineral Mist SPF-50
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
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

• Spray liberally and spread evenly by hand 15 minutes before sun exposure. • Hold 4-6 inches away from skin to apply • Reapply -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours • Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF value of ...

Storage and handling

• Protect this product from excessive heat and direct sun • May stain some fabrics • Do not use if quality seal is broken or missing

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 3.4%

Zinc Oxide 15.7%

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately.

OTC - DO NOT USE SECTION

• Do not use on damage or broken skin.

OTC - WHEN USING SECTION

• When using this product • keep out of eyes. Rinse with water to remove. • keep away from face to avoid inhaling • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 ̊F.

OTC - STOP USE SECTION

• Stop use and ask a doctor if skin rash occurs.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Spray liberally and spread evenly by hand 15 minutes before sun exposure.
• Hold 4-6 inches away from skin to apply
• Reapply
-after 80 minutes of swimming or sweating
-immediately after towel drying
-at least every 2 hours
• Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
-limit time in the sun, especially from 10am - 2pm
-wear long-sleeve shirts, pants, hats and sunglasses
• Do not spray product directly on face.
• Children under 6 months of age: ask a doctor.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

• Protect this product from excessive heat and direct sun
• May stain some fabrics
• Do not use if quality seal is broken or missing

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Alumina, Bentonite, Beta-Sitosterol, Bisabolol, Butyloctyl Salicylate, C18-21 Alkane, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Dicaprylyl Carbonate, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isononyl Isononanoate, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyester-8, Polyhydroxystearic Acid, Propanediol, Silica, Sodium Gluconate, Sodium Stearoyl Glutamate, Squalene, Tocopherol, Water

QUESTIONS?

OTC - QUESTIONS SECTION

Call us at (619) 894-6540

RECENT MAJOR CHANGES SECTION

Warnings

Directions

Other Information

Inactive ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral-Mist-TT1 (1)Mineral-Mist-TT1 (1)

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73088-107-16Mineral MistSPF-50178 mL in 1 BOTTLESPRAY1784

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73088-10773088-107-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
BETA-SITOSTEROLS347WMO6M4IACT
ISOCETYL STEAROYL STEARATEIJV4LS383RIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM GLUCONATER6Q3791S76IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
COCO GLUCOSIDEICS790225BIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ALUMINUM OXIDELMI26O6933IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
BENTONITEA3N5ZCN45CIACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C18-C21 ALKANE33822S0M40IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
SQUALENE7QWM220FJHIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT

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
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
ndc (package): 73088-107-16
ndc (product): 73088-107
ndc11 (package): 73088010716
spl id: 45614930-d406-1b58-e063-6294a90ac7d5
spl set id: dca54a19-af25-ce47-e053-2a95a90a22db

Reported adverse events (FAERS/openFDA)#

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