ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD: Package Insert and Label Information

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

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

Principal Display Panel -- Prevage City Smart Broad Spectrum SPF 50 Hydrating Shield
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE .062 g in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE .056 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
ALKYL (C12-15) BENZOATE
ISOPROPYL MYRISTATE
PENTYLENE GLYCOL
BUTYLENE GLYCOL
SILICA DIMETHYL SILYLATE
CAPRYLYL TRISILOXANE
GLYCERIN
ALUMINUM HYDROXIDE
STEARIC ACID
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
CARNOSINE
PHENOXYETHANOL
MICA
SODIUM PYRROLIDONE CARBOXYLATE
HYDROGEN DIMETHICONE (13 CST)
EDETATE DISODIUM
CHLORPHENESIN
.ALPHA.-TOCOPHEROL ACETATE
FERULIC ACID
GREEN TEA LEAF
PEG/PPG-18/18 DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
LECITHIN, SOYBEAN
STANNIC OXIDE
ARABIDOPSIS THALIANA
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE
ERGOTHIONEINE
ISODODECANE
CYCLOMETHICONE 5
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67938-3050-1 1 TUBE in 1 CARTON contains a TUBE
1 5 mL in 1 TUBE This package is contained within the CARTON (67938-3050-1)
2 NDC:67938-3050-2 1 TUBE in 1 CARTON contains a TUBE
2 40 mL in 1 TUBE This package is contained within the CARTON (67938-3050-2)
3 NDC:67938-3050-3 1 TUBE in 1 CARTON contains a TUBE
3 15 mL in 1 TUBE This package is contained within the CARTON (67938-3050-3)
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)

Revised: 08/2017 ELIZABETH ARDEN, INC

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