HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF- titanium dioxide and zinc oxide cream 
Alastin Skincare, Inc.

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HydraTint Pro Mineral Broad Spectrum Sunscreen SPF

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 8.9%Sunscreen
Zinc Oxide 3.4%Sunscreen

Uses

Warnings

  • Do not use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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:

Inactive Ingredients

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

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

PRINCIPAL DISPLAY PANEL - 91 g Tube Carton

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
HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70604-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.089 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.034 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
ECTOINE (UNII: 7GXZ3858RY)  
SQUALANE (UNII: GW89575KF9)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70604-011-9912 in 1 CARTON03/01/2022
16 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70604-011-0012 g in 1 TUBE; Type 0: Not a Combination Product03/01/2022
3NDC:70604-011-021 in 1 CARTON03/01/2022
391 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:70604-011-04130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02009/24/2021
Labeler - Alastin Skincare, Inc. (085997348)
Registrant - Wasatch Product Development, LLC (962452533)

Revised: 12/2023
Document Id: 520cc1e1-f795-44d6-b0c7-da2f92a20c8b
Set id: a564dce9-65a8-452e-8124-d97a7187ca83
Version: 1
Effective Time: 20231204
 
Alastin Skincare, Inc.