FDA.reportPublic FDA data

SPF 50 Mineral Based Facial Sunscreen

Manufacturer
Hutton, Kathleen MD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2024-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:10:22

Label at a glance#

ProductSPF 50 Mineral Based Facial Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure11 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 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor 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 value of 15 or higher and other sun protectio...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 10%

Zinc Oxide 3%

PURPOSE:

OTC - PURPOSE SECTION

Sunscreen

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 on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. 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 40 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
  • Children under 6 months: Ask a doctor
  • 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 value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 am-2 pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water

OTHER INFORMATION:

OTHER SAFETY INFORMATION

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

MANUFACTURED FOR:
Kathleeen Hutton MD
Newport Beach, CA 92660

WWW.HUTTONKLEIN.COM
800-909-0060

Principal Display Panel – 53 g Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HUTTON KLEIN
HK
DERMATOLOGISTS

SPF 50

Mineral Based
Facial Sunscreen

  • Free of Chemical Sunscreens
  • Water-Resistant (40 Minutes)
  • Broad Spectrum
  • Oil and PABA Free

Net. Wt. 1.8 oz./ 53 g

Figure
Figure

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81679-258-50SPF 50 Mineral Based Facial Sunscreen53 g in 1 BOTTLE, PUMPCREAM531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81679-258SPF 50 MINERAL BASED FACIAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [HUTTON, KATHLEEN MD]1Current NDC, 1 package rows20240329_5cf0d2e3-d496-424c-ac75-70ff5b87e9ca.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81679-25881679-258-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
BISMUTH OXYCHLORIDE4ZR792I587IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCOL00YIU5438UIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYL HYDROXYSTEARATE BENZOATE3W8F25684BIACT
GLYCERINPDC6A3C0OXIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ISODODECANEA8289P68Y2IACT
ISOHEXADECANE918X1OUF1EIACT
MELISSA OFFICINALIS WHOLEYF70189L0NIACT
MICAV8A1AW0880IACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)9713Q0S7FOIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOCOPHEROLR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT

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
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
ndc (package): 81679-258-50
ndc (product): 81679-258
ndc11 (package): 81679025850
spl id: d1612c94-e50e-4ba5-a591-a7dfa77fb5f8
spl set id: 5cf0d2e3-d496-424c-ac75-70ff5b87e9ca

Reported adverse events (FAERS/openFDA)#

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