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.

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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 Box

Eight Hour Cream Sun Defense For Face Tube


EIGHT HOUR CREAM SUN DEFENSE FOR FACE SPF 50 SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1094
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE6.159 g  in 53 g
OCTINOXATE (OCTINOXATE) OCTINOXATE3.922 g  in 53 g
OCTISALATE (OCTISALATE) OCTISALATE2.65 g  in 53 g
Inactive Ingredients
Ingredient NameStrength
WATER22.872 g  in 53 g
ALKYL (C12-15) BENZOATE6.52 g  in 53 g
ISODECYL NEOPENTANOATE4.24 g  in 53 g
NEOPENTYL GLYCOL DIHEPTANOATE2.35 g  in 53 g
MAGNESIUM ALUMINUM SILICATE0.66 g  in 53 g
GLYCERYL MONOSTEARATE0.53 g  in 53 g
PEG-100 STEARATE0.53 g  in 53 g
ARACHIDYL ALCOHOL0.379 g  in 53 g
PHENOXYETHANOL0.276 g  in 53 g
CAPRYLYL GLYCOL0.221 g  in 53 g
DOCOSANOL0.207 g  in 53 g
TRIETHOXYCAPRYLYLSILANE0.166 g  in 53 g
XANTHAN GUM0.132 g  in 53 g
EDETATE DISODIUM0.106 g  in 53 g
METHYLPARABEN0.106 g  in 53 g
ARACHIDYL GLUCOSIDE0.103 g  in 53 g
SORBIC ACID0.033 g  in 53 g
BUTYLATED HYDROXYTOLUENE0.026 g  in 53 g
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:67938-1094-11 TUBE (1 TUBE) in 1 BOXcontains a TUBE (67938-1094-2)
1NDC:67938-1094-253 g in 1 TUBEThis package is contained within the BOX (67938-1094-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/14/2010

Labeler - Elizabeth Arden, Inc (849222187)
Establishment
NameAddressID/FEIOperations
CEI032565959manufacture

Revised: 01/2011 Elizabeth Arden, Inc