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

Principal Display Panel -- Prevage Anti-Aging Foundation Carton Label
(click image for full-size original)
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

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