HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF- titanium dioxide and zinc oxide cream

HydraTint Pro Mineral Broad Spectrum Sunscreen SPF by

Drug Labeling and Warnings

HydraTint Pro Mineral Broad Spectrum Sunscreen SPF by is a Otc medication manufactured, distributed, or labeled by Alastin Skincare, Inc., Wasatch Product Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 8.9%	Sunscreen
Zinc Oxide 3.4%	Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• For external use only.

• 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

• 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

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

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

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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

INGREDIENTS AND APPEARANCE

HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70604-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.089 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.034 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70604-011-99	12 in 1 CARTON	03/01/2022
1		6 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70604-011-00	12 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2022
3	NDC: 70604-011-02	1 in 1 CARTON	03/01/2022
3		91 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 70604-011-04	130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	09/24/2021

Labeler - Alastin Skincare, Inc. (085997348)

Registrant - Wasatch Product Development, LLC (962452533)