POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN- titanium dioxide and zinc oxide lotion 
SENTÉ, 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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Pollution Shield SPF 46 Broad Spectrum Sunscreen

Drug Facts

Active ingredientsPurpose
Titanium Dioxide 5.3%Sunscreen
Zinc Oxide 14.5%Sunscreen

Uses

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

Directions

Inactive ingredients

Water (Aqua), Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Glycerin, Steareth-2, Cetearyl Alcohol, Polymethylsilsesquioxane, Steareth-21, Silica, Polyhydroxystearic Acid, Hydrolyzed Candida Saitoana Extract, Glycine Max (Soybean) Seed Extract, Yeast Extract, Biosaccharide Gum-4, Dimethicone, Dipotassium Glycyrrhizate, Propanediol, Stearic Acid, Triethoxycaprylylsilane, Sodium Stearoyl Glutamate, 1,2-Hexanediol, Sodium C14-16 Olefin Sulfonate, Caprylhydroxamic Acid, Alumina, Caprylyl Glycol, Xanthan Gum, Disodium EDTA. Iron Oxides (Cl 77491, Cl 77492, Cl 77499).

Other information

Questions or comments?

(800) 205-6774

www.sentelabs.com

PRINCIPAL DISPLAY PANEL - 52 g Tube Carton

SENTÉ
Glycosaminoglycans

Pollution Shield

Broad Spectrum
SPF 46 Sunscreen

Full Physical
Tinted

PA++++

BOOST
SHIELD

NET WT. 1.8 OZ/52g

PRINCIPAL DISPLAY PANEL - 52 g Tube Carton
POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN 
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71398-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide53 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide145 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Dicaprylyl Carbonate (UNII: 609A3V1SUA)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Glycerin (UNII: PDC6A3C0OX)  
Steareth-2 (UNII: V56DFE46J5)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
Steareth-21 (UNII: 53J3F32P58)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Soybean (UNII: L7HT8F1ZOD)  
Yeast, Unspecified (UNII: 3NY3SM6B8U)  
Biosaccharide Gum-4 (UNII: 9XRL057X90)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Propanediol (UNII: 5965N8W85T)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
1,2-Hexanediol (UNII: TR046Y3K1G)  
Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Aluminum Oxide (UNII: LMI26O6933)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Xanthan Gum (UNII: TTV12P4NEE)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Product Characteristics
ColorBROWN (Tan) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71398-001-011 in 1 CARTON06/15/2017
152 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:71398-001-041 in 1 BLISTER PACK06/15/2017
22 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:71398-001-021 in 1 CARTON06/15/2017
311.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/15/2017
Labeler - SENTÉ, Inc. (079245446)

Revised: 5/2017
Document Id: ddd7e3c9-9948-48a8-a4d3-f45004e308cb
Set id: df69d75a-4a7f-4fb3-8c84-6d06e97e2b0e
Version: 1
Effective Time: 20170512
 
SENTÉ, Inc.