Alex MD PhD Antidotal Skincare Daily Defense Tinted Mineral Anti-Aging Sunscreen

Manufacturer
AMCOL Health & Beauty Solutions, Inc. DBA AMCOL Household and Personal Care | AMCOL Health & Beauty Solutions, Inc. DBA
Effective date
2021-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:47:53

Label at a glance#

ProductAlex MD PhD Antidotal Skincare Daily Defense Tinted Mineral Anti-Aging 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 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: 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide, 6.8%

Zinc Oxide, 20.2%

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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product keep out of 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 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 swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.

Children under 6 months:

Ask a doctor.

OTC - ASK DOCTOR SECTION

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 Ingredients

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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Principal Display Panel - 65 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALEX MD PhD ANTIDOTAL SKINCARE

DAILY DEFENSE

TINTED MINERAL ANTI-AGING SUNSCREEN

BROAD SPECTRUM SPF 50+ WATER RESISTANT (80 MINUTES)

net wt 2.3 oz – 65 g

Principal Display Panel - 65 g Carton Label
Principal Display Panel - 65 g Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68634-072-012023-01-30C16284748780-1f386c649-c284-0266-e053-dadaa90a7c1aDrug Facts

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68634-07268634-072-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

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
50ec5b20-8641-4de4-9c19-8e1a4123b2d5131a23ce-ecc6-47db-8bb0-71272c0eacc02021-04-01WarningsExact identifier
spl id: 50ec5b20-8641-4de4-9c19-8e1a4123b2d5
spl set id: 131a23ce-ecc6-47db-8bb0-71272c0eacc0

Reported adverse events (FAERS/openFDA)#

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