FDA.reportPublic FDA data

HydraTint Pro Mineral Broad Spectrum Sunscreen SPF

Manufacturer
Alastin Skincare, Inc. | Wasatch Product Development, LLC
Effective date
2023-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:03:39

Label at a glance#

ProductHydraTint Pro Mineral Broad Spectrum Sunscreen SPF
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections

Indications and uses

Helps prevent sunburn.

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 of age: 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 protecti...

Storage and handling

Protect the product in this container from excessive heat and direct sun. Store at room temperature 15° - 30°C (59° - 86°F).

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.

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
  • Children under 6 months of age: 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 Ingredients

INACTIVE INGREDIENT SECTION

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

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun. Store at room temperature 15° - 30°C (59° - 86°F).

SPL UNCLASSIFIED SECTION

Distributed by
Alastin Skincare®, Inc., a Galderma Company
Carlsbad, CA 92010

PRINCIPAL DISPLAY PANEL - 91 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70604-11-02

HYDRATINT
PRO MINERAL
SUNSCREEN

ALASTIN®
SKINCARE

Broad Spectrum SPF 36 Sunscreen
Water Resistant (40 minutes)

Net Wt. 3.2 Oz. 91 g

PRINCIPAL DISPLAY PANEL - 91 g Tube Carton
PRINCIPAL DISPLAY PANEL - 91 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70604-011-002025-01-30C16284748780-12cef2736-91b4-d83d-e063-dadaa90ab31fHydraTint Pro Mineral Broad Spectrum Sunscreen SPF
70604-011-022025-01-30C16284748780-12cef2736-91b4-d83d-e063-dadaa90ab31fHydraTint Pro Mineral Broad Spectrum Sunscreen SPF
70604-011-042025-01-30C16284748780-12cef2736-91b4-d83d-e063-dadaa90ab31fHydraTint Pro Mineral Broad Spectrum Sunscreen SPF
70604-011-992025-01-30C16284748780-12cef2736-91b4-d83d-e063-dadaa90ab31fHydraTint Pro Mineral Broad Spectrum Sunscreen SPF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70604-011-00HydraTint Pro Mineral Broad Spectrum Sunscreen SPF12 g in 1 TUBECREAM121
70604-011-02HydraTint Pro Mineral Broad Spectrum Sunscreen SPF1 in 1 CARTONCREAM11
70604-011-02HydraTint Pro Mineral Broad Spectrum Sunscreen SPF91 g in 1 TUBECREAM911
70604-011-04HydraTint Pro Mineral Broad Spectrum Sunscreen SPF130 g in 1 BOTTLE, PUMPCREAM1301
70604-011-99HydraTint Pro Mineral Broad Spectrum Sunscreen SPF12 in 1 CARTONCREAM121
70604-011-99HydraTint Pro Mineral Broad Spectrum Sunscreen SPF6 g in 1 TUBECREAM61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70604-011HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [ALASTIN SKINCARE, INC.]16 package rows20231208_a564dce9-65a8-452e-8124-d97a7187ca83.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70604-01170604-011-99, 70604-011-00, 70604-011-02, 70604-011-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
STEARIC ACID4ELV7Z65APIACT
THERMUS THERMOPHILUS LYSATE775R692494IACT
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETYP81E471FIACT
SODIUM CHLORIDE451W47IQ8XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONEBO24ID7E9UIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
ERGOTHIONEINEBDZ3DQM98WIACT
ECTOINE7GXZ3858RYIACT
SQUALANEGW89575KF9IACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DIPROPYLENE GLYCOLE107L85C40IACT
PHENOXYETHANOLHIE492ZZ3TIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
520cc1e1-f795-44d6-b0c7-da2f92a20c8ba564dce9-65a8-452e-8124-d97a7187ca832023-12-04WarningsExact identifier
spl id: 520cc1e1-f795-44d6-b0c7-da2f92a20c8b
spl set id: a564dce9-65a8-452e-8124-d97a7187ca83

Reported adverse events (FAERS/openFDA)#

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