FDA.reportPublic FDA data

MUSTELA MINERAL SUNSCREEN SPRAY BROAD SPECTRUM SPF 50

Manufacturer
Expanscience Laboratories d/b/a Mustela
Effective date
2024-12-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:40:11

Label at a glance#

ProductMUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
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

Shake well before use Hold container 4 to 6 inches from the skin to apply Apply liberally 15 minutes before sun exposure Do not spray directly into face Do not spray in windy condition Use in well-ventilated area 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 ski...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.3%

Zinc Oxide 14.7%

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

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Hold container 4 to 6 inches from the skin to apply
  • Apply liberally 15 minutes before sun exposure
  • Do not spray directly into face
  • Do not spray in windy condition
  • Use in well-ventilated area
  • 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 this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other protection measures including:
  • Limit time in the sun, especially from 10 a.m - 2p.m
  • Wear long-sleeved shirt, pants, hat, and sunglasses
  • Children under 6 months: ask a doctor.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Butyloctyl Salicylate, Cocos Nucifera (Coconut) Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Heptyl Undecylenate, Methyl Dihydroabietate, Cetearyl Alcohol, Propanediol, Sodium Stearoyl Glutamate, Bentonite, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Microcrystalline Cellulose, Bisabolol*, Alumina, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Caprylhydroxamic Acid, Glycerin, Silica, Cellulose Gum, Aloe Barbadensis Leaf Juice*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Spiraea Ulmaria Flower Extract*, Nasturtium Officinale Flower/Leaf Extract*, *Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-422-2987
Monday-Friday 9:00am-5:00pm EST

Company Information

SPL UNCLASSIFIED SECTION

MADE IN THE USA from globally sourced materials for
Expanscience Laboratories Inc.,
Dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022
www.MustelaUSA.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2927-1MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50170 g in 1 BOTTLE, SPRAYSPRAY1705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64768-2927MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) SPRAY [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]5Current NDC, Legacy NDC, 1 package rows20241204_beec926c-35a5-1901-e053-2a95a90ad043.zip

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
64768-292764768-2927-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEPTYL UNDECYLENATEW77QUB6GXOIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BENTONITEA3N5ZCN45CIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO GLUCOSIDEICS790225BIACT
ALUMINUM OXIDELMI26O6933IACT
SODIUM GLUCONATER6Q3791S76IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CHAMOMILEFGL3685T2XIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LEVOMENOL24WE03BX2TIACT
ZINC OXIDESOI2LOH54ZACTIB
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
SUNFLOWER OIL3W1JG795YIIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
TOCOPHEROLR0ZB2556P8IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPANEDIOL5965N8W85TIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDE, TITANIUM DIOXIDEExpanscience Laboratories d/b/a Mustelabeec926c-35a5-1901-e053-2a95a90ad0432024-12-02WarningsExact identifier
ndc (package): 64768-2927-1
ndc (product): 64768-2927
ndc11 (package): 64768292701
spl id: 284b7df4-05eb-a079-e063-6394a90a2ba7
spl set id: beec926c-35a5-1901-e053-2a95a90ad043

Reported adverse events (FAERS/openFDA)#

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