ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30: Package Insert and Label Information

ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30- octinoxate and titanium dioxide 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 Ingredients

OCTINOXATE 6.0%

TITANIUM DIOXIDE 6.0%

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

WATER/AQUA/EAU, CYCLOPENTASILOXANE, DICAPRYLYL CARBONATE, MYRISTYL TRISILOXANE, POLYMETHYLSILSESQUIOXANE, CYCLOHEXASILOXANE, SORBITAN ISOSTEARATE, ALUMINA, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, GLYCERIN, TETRAHEXYLDECYL ASCORBATE, TRIMETHYLSILOXYSILICATE, MICA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, CAMELLIA SINENSIS LEAF EXTRACT, CARNOSINE, DIMETHICONE, DIMETHICONOL, DISODIUM COCOYL GLUTAMATE, ERGOTHIONEINE, FERULIC ACID, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, PARFUM/FRAGRANCE, PCA DIMETHICONE, POLYHYDROXYSTEARIC ACID, SILICA, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM COCOYL GLUTAMATE, STEARIC ACID, TOCOPHEROL, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Other Information

• Protect this product from excessive heat and direct sun

Questions or comments?

• Call toll free 1-800 326-7337

Principal Display Panel — Prevage Anti-Aging Foundation Carton Label

prevage ^®

anti-aging foundation

broad spectrum sunscreen

SPF 30

1 FL. OZ. 30 ml

ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30 octinoxate, titanium dioxide lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-3051 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE .06 g in 1 mL TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE .06 g in 1 mL

Inactive Ingredients Ingredient Name Strength WATER CYCLOMETHICONE 5 DICAPRYLYL CARBONATE MYRISTYL TRISILOXANE CYCLOMETHICONE 6 SORBITAN ISOSTEARATE ALUMINUM OXIDE GLYCERIN TETRAHEXYLDECYL ASCORBATE MICA GREEN TEA LEAF CARNOSINE DIMETHICONE DISODIUM COCOYL GLUTAMATE ERGOTHIONEINE FERULIC ACID HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE SILICON DIOXIDE SODIUM CHLORIDE SODIUM COCOYL GLUTAMATE STEARIC ACID TOCOPHEROL CHLORPHENESIN PHENOXYETHANOL POTASSIUM SORBATE SODIUM DEHYDROACETATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67938-3051-1 1 BOTTLE in 1 CARTON contains a BOTTLE 1 30 mL in 1 BOTTLE This package is contained within the CARTON (67938-3051-1)

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