DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30- avobenzone, octocrylene and oxybenzone lotion 
DUANE READE 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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ACTIVE INGREDIENTS:

Avobenzone 1.0 %

Octocrylene 4.5 %

Oxybenzone 3.0%

Purpose

Sunscreen

Uses

WARNINGS:

FOR EXTERNAL USE ONLY.

When using this product

keep out of eyes. Rinse with water to remove.

stop use and ask a doctor if

rash or irritation develops and lasts

keep out of the reach of children. If swallowed get medical help or contact a poison control center right away.

Directions:

apply generously and evenly before sun exposure and as needed

Other Information:

May stain some fabrics.

INACTIVE INGREDIENTS:

Water, Ethyhexyl Palmitate, Lauryl PEG-8 Dimethicone, Hexyldecanol, Cyclopentasiloxane, Hydrated Silica, Cyclohexasiloxane, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methcrylate Copolymer, Cetyl Dimethicone, Sodium Chloride, Beeswax, Microcrystalline Wax, Polyethylene, PEG-4 Laurate, Stearoxy dimethicone, PEG-4, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice, OCtyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate,Silica, Methylparaben,Propylparaben, Disodium EDTA, Iodopropynyl Butylcarbamate, Fragrance.

Principal Display Panel

PRevail

moisturizing sunscreen

spf 30

6.5 FL. OZ. (192 mL)ZDR015A0f.jpgZDR015A0b.jpg

DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 30
avobenzone lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67732-411
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 4.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
HEXYLDECANOL (UNII: 151Z7P1317)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PEG-4 DILAURATE (UNII: KCR71CW036)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POLYETHYLENE GLYCOL 200 (UNII: R95B8J264J)  
PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:67732-411-55 184 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/14/2012
Labeler - DUANE READE INC. (011988995)

Revised: 11/2012
Document Id: 7b73105e-5cb6-42ce-9f93-ef8daa2976e3
Set id: 03de9560-6fdf-44e5-b63b-d8cba070d33d
Version: 1
Effective Time: 20121114
 
DUANE READE INC.