DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30- avobenzone lotion

Duane Reade Prevail Moisturizing Sunscreen by

Drug Labeling and Warnings

Duane Reade Prevail Moisturizing Sunscreen by is a Otc medication manufactured, distributed, or labeled by DUANE READE INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Avobenzone 1.0 %

Octocrylene 4.5 %

Oxybenzone 3.0%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Retains SPF after 80 minutes of activity in the water
  

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

• Children under 6 months of age:ask a doctor
• reapplying frequently after towel drying, swimming or perspiring.

Other Information:

May stain some fabrics.

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

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

• antioxidant-enriched
• uva/uvb protection
• hypoallergic
• oil-free

6.5 FL. OZ. (192 mL)

INGREDIENTS AND APPEARANCE

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

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)