Label: ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-3050-1, 67938-3050-2, 67938-3050-3 - Packager: ELIZABETH ARDEN, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated August 1, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
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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
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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
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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
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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
- Questions or Comments?
- Principal Display Panel - Prevage City Smart Broad Spectrum SPF 50 Hydrating Shield
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INGREDIENTS AND APPEARANCE
ELIZABETH ARDEN PREVAGE CITY SMART BROAD SPECTRUM SPF 50 HYDRATING SHIELD
titanium dioxide, zinc oxide lotionProduct 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)
