ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD- titanium dioxide, zinc oxide lotion

ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD by

Drug Labeling and Warnings

ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

TITANIUM DIOXIDE 6.2% W/W

ZINC OXIDE 5.6% W/W

Purpose

Sunscreen

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 For Sunscreen Use:

• 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 of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
• Children under 6 months: Ask a doctor

Inactive Ingredients

CYCLOPENTASILOXANE, WATER/AQUA/EAU, ISODODECANE, DIMETHICONE, C12-15 ALKYL BENZOATE, ISOPROPYL MYRISTATE, PENTYLENE GLYCOL, BUTYLENE GLYCOL, SILICA DIMETHYL SILYLATE, CAPRYLYL METHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ACRYLATES/POLYTRIMETHYLSILOXYMETHACRYLATE COPOLYMER, GLYCERIN, ALUMINUM HYDROXIDE, STEARIC ACID, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, CARNOSINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ARABIDOPSIS THALIANA EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, CAPRYLYL GLYCOL, DISODIUM EDTA, ERGOTHIONEINE, FERULIC ACID, HYDROGEN DIMETHICONE, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, MICROCOCCUS LYSATE, PARFUM/FRAGRANCE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SODIUM PCA, TIN OXIDE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, ALPHA-ISOMETHYL IONONE, LINALOOL, CHLORPHENESIN, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Other Information

• Protect this product from excessive heat and direct sun
• Store at room temperature

Questions or Comments?

Call toll free 1-800 326-7337

Principal Display Panel - Prevage City Smart Broad Spectrum SPF 50 Hydrating Shield

prevage®

city smart

+ DNA enzyme complex™

+ anti-pollution

+ antioxidants

broad spectrum SPF 50

hydrating shield

1.34 FL. OZ. 40 ml

INGREDIENTS AND APPEARANCE

ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-3050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	.062 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	.056 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
CARNOSINE (UNII: 8HO6PVN24W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CHLORPHENESIN (UNII: I670DAL4SZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FERULIC ACID (UNII: AVM951ZWST)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
STANNIC OXIDE (UNII: KM7N50LOS6)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
ISODODECANE (UNII: A8289P68Y2)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-3050-1	1 in 1 CARTON	08/01/2017
1		5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67938-3050-2	1 in 1 CARTON	08/01/2017
2		40 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 67938-3050-3	1 in 1 CARTON	08/01/2017
3		15 mL 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 not final	part352	08/01/2017

Labeler - ELIZABETH ARDEN, INC (849222187)