HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF 36- titanium dioxide and zinc oxide cream

HydraTint Pro Mineral Broad Spectrum Sunscreen SPF 36 by

Drug Labeling and Warnings

HydraTint Pro Mineral Broad Spectrum Sunscreen SPF 36 by is a Otc medication manufactured, distributed, or labeled by Alastin Skincare, Inc., Universal Packaging Systems, Inc (DBA: PakLab). 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.
• 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

• 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
• 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

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

• 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

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

INGREDIENTS AND APPEARANCE

HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF 36 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70604-010
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
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Butylene Glycol (UNII: 3XUS85K0RA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Dimethicone/Vinyl Dimethicone Crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
Dunaliella Salina (UNII: F4O1DKI9A6)
Ergothioneine (UNII: BDZ3DQM98W)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Peg/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)
PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: TYP81E471F)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 MPA.S) (UNII: RLA2U05Z4Q)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)
Squalane (UNII: GW89575KF9)
Stearic acid (UNII: 4ELV7Z65AP)
Thermus Thermophilus Lysate (UNII: 775R692494)
Tocopherol (UNII: R0ZB2556P8)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Water (UNII: 059QF0KO0R)
Green Tea Leaf (UNII: W2ZU1RY8B0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70604-010-02	1 in 1 CARTON	01/01/2017
1		74 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70604-010-99	12 in 1 CARTON	01/01/2017
2		6 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 70604-010-00	15 g in 1 TUBE; Type 0: Not a Combination Product	08/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	01/01/2017

Labeler - Alastin Skincare, Inc. (085997348)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc (DBA: PakLab)		790530976	MANUFACTURE(70604-010)