FDA.reportPublic FDA data

ALEX MD PHD Tinted Mineral Sunscreen

Manufacturer
PHYSICIAN LABORATORIES INC
Effective date
2025-03-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:04

Label at a glance#

ProductALEX MD PHD Tinted Mineral Sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
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

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimmingor 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 of 15 or higher and other sun protection m...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide, 20.2%
Titanium Dioxide, 6.8%

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

Warnings

WARNINGS SECTION

  • For external use only
  • Do not use ondamaged or broken skin.
  • When using this productkeep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctorif rash occurs.
  • Keep out of reach of children.If product is 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 swimmingor 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 of 15 or higher and other sun protection measures including:
   •Limit time in the sun, especially from 10am–2pm.
   •Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive igredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Water/Aqua/Eau, Coco-Caprylate /Caprate, Isononyl Isononanoate, Polyglyceryl-3 Polydimethylsiloxyethyl
Dimethicone, Glycerin, Disteardimonium Hectorite, Aluminum Hydroxide, Stearic Acid, Undaria Pinnatifida Extract, Triethoxysilylethyl
Polydimethylsiloxyethyl Hexyl Dimethicone, Astrocaryum Tucuma Seed Butter, Butyrospermum Parkii (Shea) Butter, Theobroma Grandiflorum
Seed Butter, Tetrahexyldecyl Ascorbate, Dunaliella Salina Extract, Bisabolol, Ubiquinone, Ergothioneine,Tremella Fuciformis Sporocarp Extract,
Tocopheryl Acetate, Betaine, Lavandula Angustifolia (Lavender) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Polyglyceryl-3 Diisostearate, PEG/PPG-18/18 Dimethicone, Caprylyl Glycol, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Squalane, Polyglyceryl-3 Polyricinoleate,
C12-15 Alkyl Benzoate, Disodium EDTA, Sodium Chloride, Phenoxyethanol, Ethylhexylglycerin, Iron Oxides (CI 77491, 77499, 77492)

Other information

SPL UNCLASSIFIED SECTION

Protect this product from excessive heat and direct sun.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78709-002-01ALEX MD PHD Tinted Mineral Sunscreen1 in 1 CARTONCREAM11
78709-002-01ALEX MD PHD Tinted Mineral Sunscreen65 g in 1 TUBECREAM651

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78709-002ALEX MD PHD TINTED MINERAL SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [PHYSICIAN LABORATORIES INC]1Current NDC, 2 package rows20250330_93873c34-5c72-43c8-b6c2-c65b596191d7.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78709-00278709-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 41 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB
ERGOTHIONEINEBDZ3DQM98WIACT
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BETAINE3SCV180C9WIACT
LAVENDER OILZBP1YXW0H8IACT
ORANGE OIL, COLD PRESSEDAKN3KSD11BIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
SQUALANEGW89575KF9IACT
CYCLOMETHICONE 50THT5PCI0RIACT
WATER059QF0KO0RIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
GLYCERINPDC6A3C0OXIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
UNDARIA PINNATIFIDAICV1OK7M1SIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
ASTROCARYUM VULGARE KERNEL OIL1IQY04O559IACT
SHEA BUTTERK49155WL9YIACT
THEOBROMA GRANDIFLORUM SEED BUTTERI711F13FXMIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
LEVOMENOL24WE03BX2TIACT

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
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
ndc (package): 78709-002-01
ndc (product): 78709-002
ndc11 (package): 78709000201
spl id: 31682e51-745b-885d-e063-6394a90ae601
spl set id: 93873c34-5c72-43c8-b6c2-c65b596191d7

Reported adverse events (FAERS/openFDA)#

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