FDA.reportPublic FDA data

Mineral Lip Sunscreen

Manufacturer
Hutton, Kathleen MD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2025-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:01

Label at a glance#

ProductMineral Lip Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure8 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 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 s...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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.

OTC - DO NOT USE SECTION

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 80 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 10:00 a.m.-2:00 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

OTHER SAFETY INFORMATION

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

Not tested on animals

Principal Display Panel – 4.5 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HUTTON KLEIN

HK
DERMATOLOGISTS

Mineral Lip
Sunscreen

SPF 45

broad spectrum

water resistant

(80 mins)

Tinted

Net. Wt. .14 oz./ 4.5 g

Principal Display Panel – 4.5 g Tube Label
Principal Display Panel – 4.5 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81679-212-45Mineral Lip Sunscreen4.5 g in 1 TUBESTICK4.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81679-212MINERAL LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [HUTTON, KATHLEEN MD]2Current NDC, 1 package rows20250119_2be51fdf-c3f2-463b-8c7d-bda07db17e1b.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81679-21281679-212-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
ALUMINUM OXIDELMI26O6933IACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ALUMINUM STEARATEU6XF9NP8HMIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CETEARYL ISONONANOATEP5O01U99NIIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)8INO2K35FAIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIPROPYLENE GLYCOL CAPRYLATECJ981S4H3TIACT
ETHYLHEXYL PALMITATE2865993309IACT
CITRUS AURANTIIFOLIA FRUIT OIL7937R189CBIACT
KIWI FRUIT OIL66086CWP3QIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
HEXYLDECANOL151Z7P1317IACT
HEXYL LAURATE4CG9F9W01QIACT
FERRIC OXIDE RED1K09F3G675IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
CERESINQ1LS2UJO3AIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GINGER OILSAS9Z1SVUKIACT

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
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
ndc (package): 81679-212-45
ndc (product): 81679-212
ndc11 (package): 81679021245
spl id: fa35b637-9c8c-4c55-a3b6-d7961938f918
spl set id: 2be51fdf-c3f2-463b-8c7d-bda07db17e1b

Reported adverse events (FAERS/openFDA)#

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