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

ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30 by

Drug Labeling and Warnings

ELIZABETH ARDEN PREVAGE ANTI-AGING FOUNDATION BROAD SPECTRUM SUNSCREEN SPF 30 by is a Otc medication manufactured, distributed, or labeled by ELIZABETH ARDEN, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	.06 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	.06 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
MICA (UNII: V8A1AW0880)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARNOSINE (UNII: 8HO6PVN24W)
DIMETHICONE (UNII: 92RU3N3Y1O)
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
FERULIC ACID (UNII: AVM951ZWST)
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE (UNII: OV1BT2N8RC)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-3051-1	1 in 1 CARTON	08/01/2017
1		30 mL in 1 BOTTLE; 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)