FDA.reportPublic FDA data

MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50

Manufacturer
Expanscience Laboratories d/b/a Mustela
Effective date
2025-06-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:02:07

Label at a glance#

ProductMUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed wtih 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 to exposed areas 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: li...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed wtih 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 - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of the eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally to exposed areas 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, expecially from 10 a.m. - 2 p.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

WATER, C15-19 ALKANE, GLYCERIN, POLYGLYCERYL-3 POLYRICINOLEATE, ETHYL MACADAMIATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, STYRENE/ACRYLATES COPOLYMER, STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, MAGNESIUM SULFATE, SODIUM CHLORIDE, CAPRYLHYDROXAMIC ACID, TOCOPHERYL ACETATE, SODIUM HYALURONATE, TOCOPHEROL, MALIC ACID

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 - 100ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64768-2924-1MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50100 mL in 1 TUBELOTION1006
64768-2924-2MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50500 mL in 1 BOTTLE, PUMPLOTION5006
64768-2924-3MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50325 mL in 1 BOTTLE, PUMPLOTION3256

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64768-292464768-2924-1, 64768-2924-2, 64768-2924-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
PROPANEDIOL5965N8W85TIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
SODIUM CHLORIDE451W47IQ8XIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
HYALURONATE SODIUMYSE9PPT4THIACT
MALIC ACID817L1N4CKPIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
C15-19 ALKANECI87N1IM01IACT
ETHYL MACADAMIATEANA2NCS6V1IACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT

Source Document#

Source XML · Source PDF

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 OXIDEExpanscience Laboratories d/b/a Mustela95ea5442-a7ca-0c7d-e053-2a95a90ad2472025-06-02WarningsExact identifier
ndc (package): 64768-2924-3
ndc (package): 64768-2924-2
ndc (package): 64768-2924-1
ndc (product): 64768-2924
ndc11 (package): 64768292403
ndc11 (package): 64768292402
ndc11 (package): 64768292401
spl id: 369e880d-d765-f24b-e063-6394a90af418
spl set id: 95ea5442-a7ca-0c7d-e053-2a95a90ad247

Reported adverse events (FAERS/openFDA)#

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