POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN- titanium dioxide and zinc oxide lotion

Pollution Shield SPF 46 Broad Spectrum Sunscreen by

Drug Labeling and Warnings

Pollution Shield SPF 46 Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by SENTÉ, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Titanium Dioxide 5.3%	Sunscreen
Zinc Oxide 14.5%	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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 10a.m.-2p.m.
  • Wear long- sleeved shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: Ask a doctor

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

• Protect the product in this container from excessive heat and direct sun

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

INGREDIENTS AND APPEARANCE

POLLUTION SHIELD SPF 46 BROAD SPECTRUM SUNSCREEN 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71398-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	53 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	145 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71398-001-01	1 in 1 CARTON	06/15/2017
1		52 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71398-001-04	1 in 1 BLISTER PACK	06/15/2017
2		2 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 71398-001-02	1 in 1 CARTON	06/15/2017
3		11.3 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	06/15/2017

Labeler - SENTÉ, Inc. (079245446)