SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY- zinc oxide cream 
Alastin Skincare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SilkShield® All Mineral Sunscreen with TriHex Technology®

Drug Facts

Active Ingredients

Zinc Oxide 19.95%

Purpose

Sunscreen

Uses

Warnings

  • 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 value of 15 or higher and other sun protection measures including:

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

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

PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton
SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70604-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1995 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70604-030-021 in 1 CARTON09/17/2021
153.8 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:70604-030-04113 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
3NDC:70604-030-9912 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
4NDC:70604-030-0012 in 1 CARTON10/01/2021
45 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/17/2021
Labeler - Alastin Skincare, Inc. (085997348)
Registrant - Wasatch Product Development, LLC (962452533)
Establishment
NameAddressID/FEIBusiness Operations
Wasatch Product Development, LLC962452533MANUFACTURE(70604-030)
Establishment
NameAddressID/FEIBusiness Operations
Bentley Labs068351753MANUFACTURE(70604-030)

Revised: 9/2022
Document Id: 61491293-3ab7-48ba-bb35-a97b8eba669f
Set id: ee964348-a8a5-402c-8a96-abe56c031e7f
Version: 1
Effective Time: 20220923
 
Alastin Skincare, Inc.