FDA.reportPublic FDA data

MUSTELA MINERAL SUNSCREEN SPRAY BROAD SPECTRUM SPF 30

Manufacturer
Expanscience Laboratories d/b/a Mustela
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:28

Label at a glance#

ProductMUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
Active ingredientZINC 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. Higher SPF gives more sunburn protection

Dosage and administration

Shake well before use Apply liberally 15 minutes before sun exposure Hold container 4 to 6 inches from the skin to apply Do not spray directly into face Do not spray in windy conditions 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 sk...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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.
  • Higher SPF gives more sunburn protection

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before use
  • Apply liberally 15 minutes before sun exposure
  • Hold container 4 to 6 inches from the skin to apply
  • Do not spray directly into face
  • Do not spray in windy conditions
  • 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 sun 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, BUTYLOCTYL SALICYLATE, BENTONITE, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, HEPTYL UNDECYLENATE, METHYL DIHYDROABIETATE, CETEARYL ALCOHOL, CAPRYLYL GLYCOL, COCO-GLUCOSIDE,
JOJOBA ESTERS, CAPRYLHYDROXAMIC ACID, GLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, ALOE BARBADENSIS LEAF JUICE, CALENDULA OFFICINALIS FLOWER EXTRACT*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, PUERARIA LOBATA ROOT EXTRACT*, SPIRAEA ULMARIA FLOWER EXTRACT*. *CERTIFIED ORGANIC INGREDIENTS

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun. May stain some fabrics. You may report a serious adverse event to the phone number or address provided below.

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
For sale only through select retailers.
Best used before end of: see bottom

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mustela

baby - child

MINERAL

SUNSCREEN

SPRAY

BODY

DERMATOLOGIST TESTED

BROAD SPECTRUM

SPF 30

WATER RESISTANT

(80 MINUTES)

ULTRA SHEER - NON-NANO

FOR BABIES, CHILDREN AND THE ENTIRE FAMILY

SAFE FOR SENSITIVE SKIN TYPES

0% FRAGRANCE AND PARABENS

6 fl oz - 177 mL

mineral spraymineral spray

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64768-292564768-2925-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILEFGL3685T2XIACT
PUERARIA MONTANA VAR. LOBATA ROOTPET93F4I3CIACT
WATER059QF0KO0RIACT
BENTONITEA3N5ZCN45CIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CAPRYLYL GLYCOL00YIU5438UIACT
COCO GLUCOSIDEICS790225BIACT
ZINC OXIDESOI2LOH54ZACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
SAFFLOWER OIL65UEH262ISIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
ALOE VERA LEAFZY81Z83H0XIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT

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
284b3019-91c6-b146-e063-6394a90acac0a9dc4e17-c3d3-f18f-e053-2995a90a89452024-12-02WarningsExact identifier
spl set id: a9dc4e17-c3d3-f18f-e053-2995a90a8945

Reported adverse events (FAERS/openFDA)#

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