SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY- zinc oxide cream

SilkShield All Mineral Sunscreen with TriHex Technology by

Drug Labeling and Warnings

SilkShield All Mineral Sunscreen with TriHex Technology by is a Otc medication manufactured, distributed, or labeled by Alastin Skincare, Inc., Wasatch Product Development, LLC, Bentley Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 19.95%

Purpose

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 two 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 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

Inactive Ingredients

Dimethicone, Cyclopentasiloxane, Polysilicone-11, Squalane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Palmitoyl Hexapeptide-12, Palmitoyl Tripeptide-1, Dunaliella Salina Extract, Ectoin, Hydroxymethoxyphenyl Decanone, Tocopherol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Disteardimonium Hectorite, Pentaerythrityl Tetraisostearate, Propylene Carbonate

Other Information

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton

NDC: 70604-030-02

SilkSHIELD®
ALL MINERAL
SUNSCREEN
with TriHex Technology®

ALASTIN®
SKINCARE

Broad Spectrum SPF 30 Sunscreen
Water Resistant (40 minutes)

1.9 Oz. 53.8g

INGREDIENTS AND APPEARANCE

SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70604-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1995 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
ECTOINE (UNII: 7GXZ3858RY)
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70604-030-02	1 in 1 CARTON	09/17/2021
1		53.8 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 70604-030-04	113 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2021
3	NDC: 70604-030-99	12 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2021
4	NDC: 70604-030-00	12 in 1 CARTON	10/01/2021
4		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/17/2021

Labeler - Alastin Skincare, Inc. (085997348)

Registrant - Wasatch Product Development, LLC (962452533)

Establishment
Name	Address	ID/FEI	Business Operations
Wasatch Product Development, LLC		962452533	MANUFACTURE(70604-030)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Labs		068351753	MANUFACTURE(70604-030)