FDA.reportPublic FDA data

MUSTELA MINERAL SUNSCREEN 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 00:40:17

Label at a glance#

ProductMUSTELA MINERAL SUNSCREEN SPF 50
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.

Dosage and administration

Apply liberally 15 minutes before sun exposure 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 19.7%

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • 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.

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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ORYZA SATIVA (RICE) BRAN OIL*, PERSEA GRATISSIMA (AVOCADO) OIL*, EUPHORBIA CERIFERA (CANDELILLA) WAX, OCTYLDODECYL OLEATE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL*, BEESWAX*, THEOBROMA CACAO (COCOA) SEED BUTTER*, ORYZANOL, JOJOBA ESTERS, BUTYROSPERMUM PARKII (SHEA) BUTTER*, BISABOLOL*, CALENDULA OFFICINALIS FLOWER EXTRACT*, CALOPHYLLUM INOPHYLLUM SEED OIL*, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT*, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL*, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT*, SPIRAEA ULMARIA FLOWER EXTRACT*, TOCOPHEROL

*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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2926-1MUSTELA MINERAL SUNSCREEN SPF 5017 g in 1 TUBESTICK175
64768-2926-1MUSTELA MINERAL SUNSCREEN SPF 501 in 1 CARTONSTICK15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64768-2926MUSTELA MINERAL SUNSCREEN SPF 50 (ZINC OXIDE) STICK [EXPANSCIENCE LABORATORIES D/B/A MUSTELA]5Current NDC, Legacy NDC, 2 package rows20241205_b850f68e-4f52-6902-e053-2995a90aaa91.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64768-292664768-2926-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHAMOMILEFGL3685T2XIACT
AVOCADO OIL6VNO72PFC1IACT
YELLOW WAX2ZA36H0S2VIACT
ORYZANOLSST9XCL51MIACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
LEVOMENOL24WE03BX2TIACT
ZINC OXIDESOI2LOH54ZACTIB
TAMANU OILJT3LVK84A1IACT
NASTURTIUM OFFICINALE FLOWERING TOPW1N2U8I64GIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
FILIPENDULA ULMARIA FLOWER06L18L32G6IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
RICE BRAN OILLZO6K1506AIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
TOCOPHEROLR0ZB2556P8IACT
CANDELILLA WAXWL0328HX19IACT

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 SPF 50ZINC OXIDEExpanscience Laboratories d/b/a Mustelab850f68e-4f52-6902-e053-2995a90aaa912024-12-02WarningsExact identifier
ndc (package): 64768-2926-1
ndc (product): 64768-2926
ndc11 (package): 64768292601
spl id: 284bae29-bf32-43d8-e063-6394a90a041f
spl set id: b850f68e-4f52-6902-e053-2995a90aaa91

Reported adverse events (FAERS/openFDA)#

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