RxNorm Names

Not yet provided

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30 (avobenzone) lotion
[DUANE READE INC.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=03de9560-6fdf-44e5-b63b-d8cba070d33d

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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)

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 (AVOBENZONE)	AVOBENZONE	1 g in 100 g
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	4.5 g in 100 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	3 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
ETHYLHEXYL PALMITATE
HEXYLDECANOL
CYCLOMETHICONE 5
HYDRATED SILICA
CYCLOMETHICONE 6
BENZYL ALCOHOL
SODIUM CHLORIDE
YELLOW WAX
MICROCRYSTALLINE WAX
HIGH DENSITY POLYETHYLENE
PEG-4 DILAURATE
EDETATE DISODIUM
POLYETHYLENE GLYCOL 200
PEG-8 DIMETHICONE
ALOE VERA LEAF
OCTYLDODECANOL
VITAMIN A PALMITATE
SILICON DIOXIDE
.ALPHA.-TOCOPHEROL ACETATE
ASCORBIC ACID
METHYLPARABEN
PROPYLPARABEN
IODOPROPYNYL BUTYLCARBAMATE

Packaging
#	Item Code	Package Description
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.

Daily Med

Current Medication Information

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