Eight Hour Cream Sun Defense For Face SPF 50 Sunscreen: Package Insert and Label Information

EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN- zinc oxide, octinoxate and octisalate 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.

DESCRIPTION

Provides powerful SPF 50 PA+++ protection to shield against UVA/UVB rays that can cause sunburn, surface skin cell damage and premature signs of aging. Lightweight, oil-free lotion helps protect your skin from sun exposure while hydrating for up to 8 hours. PABA free.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.

INDICATIONS AND USAGE

Directions: Apply liberally and evenly to face 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming, or perspiring. Children under 6 months of age: ask a doctor.

WARNINGS

Warnings: For external use only. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor is rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC — ACTIVE INGREDIENT

Active Ingredients: Zinc Oxide 11.62% w/w, Octinoxate 7.40% w/w, Octisalate 5.00% w/w.

INACTIVE INGREDIENT

Water/Aqua/Eau, C12-25 Alkyl Benzoate, Isodecyl Neopentanoate, Neopentyl Glycol Diheptanoate, Magnesium Aluminum Silicate, Glyceryl Stearate, PEG-100 Stearate, Caprlyl Glycol, Arachidyl Alcohol, Polyhydroxystearic Acid, Arachidyl Glucoside, Triethoxycaprylylsilane, Behenyl Alcohol, Xanthan Gum, BHT, Disodium EDTA, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Methylparaben, Phenoxyethanol, Sorbic Acid.

DOSAGE & ADMINISTRATION

Apply liberally and evenly to face.

OTC — KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC — PURPOSE

Helps prevent sunburn. Higher SPF gives more sunburn protection.

OTC — WHEN USING

Keep out of eyes.

EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN zinc oxide lotion

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-1094 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 6.159 g in 53 g OCTINOXATE (OCTINOXATE) OCTINOXATE 3.922 g in 53 g OCTISALATE (OCTISALATE) OCTISALATE 2.65 g in 53 g

Inactive Ingredients Ingredient Name Strength WATER ALKYL (C12-15) BENZOATE ISODECYL NEOPENTANOATE NEOPENTYL GLYCOL DIHEPTANOATE MAGNESIUM ALUMINUM SILICATE GLYCERYL MONOSTEARATE PEG-100 STEARATE ARACHIDYL ALCOHOL PHENOXYETHANOL CAPRYLYL GLYCOL DOCOSANOL TRIETHOXYCAPRYLYLSILANE XANTHAN GUM EDETATE DISODIUM METHYLPARABEN ARACHIDYL GLUCOSIDE SORBIC ACID BUTYLATED HYDROXYTOLUENE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:67938-1094-1 1 TUBE (1 TUBE) in 1 BOX contains a TUBE (67938-1094-2) 1 NDC:67938-1094-2 53 g in 1 TUBE This package is contained within the BOX (67938-1094-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/14/2010

Labeler — Elizabeth Arden, Inc (849222187)

Revised: 01/2011 Elizabeth Arden, Inc