Duane Reade Prevail Moisturizing Sunscreen Spf 30 (Avobenzone) Lotion [Duane Reade Inc.] -

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30 (AVOBENZONE) LOTION [DUANE READE INC.]
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NDC	67732-411-55
Set ID	03de9560-6fdf-44e5-b63b-d8cba070d33d
Category	HUMAN OTC DRUG LABEL
Packager	DUANE READE INC.
Generic Name
Product Class
Product Number
Application Number	PART352

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67732-411-55	184 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/14/2012

Labeler - DUANE READE INC. (011988995)

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Medic

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30 (AVOBENZONE) LOTION [DUANE READE INC.]

When using this product

stop use and ask a doctor if

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