Duane Reade Prevail Moisturizing Sunscreen Spf 50 (Avobenzone) Lotion [Duane Reade Inc.] -

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 50 (AVOBENZONE) LOTION [DUANE READE INC.]
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NDC	67732-412-55
Set ID	2a0672cd-35f1-4025-93ef-dbda7a790472
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 2.0 %
Octocrylene 8.0 %
Oxybenzone 4.0%
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
- Reapply 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, C12-15 Alkyl Benzoate, Polyglyceryl-3 Methylglucose Distearate, Acrylates/C12-22 Alkyl methacrylate Copolymer, Hydrated Silica, Dimethicone, Glyceryl Stearate, PEG_100 Stearate, Sodium Polyacrylate, Benzyl Alcohol, Disodium EDTA, PEG_8 Dimethicone, Aloe Barbadensis leaf Juice, Octyldodecanol, Retinyl Palmitate, Silica, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Iodopropynyl Butylcarbamate, Propylparaben, Fragrance.
Principal Display Panel
PRevail

moisturizing sunscreen

spf 50
- antioxidant-enriched
- uva/uvb protection
- hypoallergic
- oil-free
6.5 FL. OZ. (192 mL)

INGREDIENTS AND APPEARANCE

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 50
avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67732-412
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67732-412-55	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 50 (AVOBENZONE) LOTION [DUANE READE INC.]

When using this product

stop use and ask a doctor if

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