HydraTint Pro Mineral Broad Spectrum Sunscreen SPF 36

Manufacturer
Alastin Skincare, Inc. | Universal Packaging Systems, Inc (DBA: PakLab)
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:44:16

Label at a glance#

ProductHydraTint Pro Mineral Broad Spectrum Sunscreen SPF 36
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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 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...

Storage and handling

Store at room temperature 15º - 30ºC (59º - 86ºF).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Titanium Dioxide 8.9%Sunscreen
Zinc Oxide 3.4%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 40 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 value 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.
  • Children under 6 months of age: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Hydroxide, Asteriscus Graveolens Flower/Fruit/Leaf/Stem Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dunaliella Salina Extract, Ergothioneine, Ethylhexylglycerin, Glycerin, Iron Oxides (C.I. 77491), Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77499), PEG/PPG-18/18 Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenoxyethanol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Sodium Citrate, Squalane, Stearic Acid, Thermus Thermophillus Ferment, Tocopheryl Acetate, Tocopherol, Triethoxycaprylylsilane, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Water/Aqua/Eau.

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 15º - 30ºC (59º - 86ºF).

SPL UNCLASSIFIED SECTION

Distributed by Alastin Skincare, Inc.
Carlsbad, CA 92010.

PRINCIPAL DISPLAY PANEL - 74 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70604-010-02

HYDRATINT PRO MINERAL
BROAD SPECTRUM
SUNSCREEN SPF 36

ALASTIN™
SKINCARE

WATER RESISTANT (40 MINUTES)

Net Wt. 2.6 oz. 74 g

PRINCIPAL DISPLAY PANEL - 74 g Tube Carton
PRINCIPAL DISPLAY PANEL - 74 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70604-01070604-010-02, 70604-010-99, 70604-010-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
a67b32ea-ffc9-4f8b-a849-8ecf56a125c5b65d0a5f-9175-453b-ad3f-f7899c8690092023-12-05WarningsExact identifier
spl set id: b65d0a5f-9175-453b-ad3f-f7899c869009

Reported adverse events (FAERS/openFDA)#

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