RxNorm Names

Not yet provided

DUANE READE OIL FREE SUNSCREEN SPF 30 (avobenzone) lotion
[DUANE READE INC.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b6e09f9a-167e-477e-869a-82024c396d32

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 2.0 %

Homosalate 13.0%

Octisalate 5.0%

Octocrylene 2.0%

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 reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Other Information

may stain some materials

Directions

shake well
apply generously before sun exposure and as needed
Children under 6 months of age:ask a doctor
reapplying frequently after towel drying, swimming or perspiring.

Inactive Ingredients

Water, Stearic Acid, Sorbitol,Triethanolamine,VP/Eicosene Copolymer, Aluminium Starch Octenylsuccinate, Benzyl Alcohol, Sorbitan Isostearate, Dimethicone, Polyglyceryl-3 Diastearate, Fragrance, Methylparaben, Carbomer, Tocopherol, Propylparaben, Disodium EDTA

Principal Display Panel

UNIQUELY NY DRTM SINCE 1960

oil free

sunscreen

30

SPF

moisturizing lotion

UVA/UVB Protection

Very Water Resistant

8 FL OZ (237 mL)

DUANE READE OIL FREE SUNSCREEN SPF 30
avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67732-402
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (AVOBENZONE)	AVOBENZONE	2 g in 100 g
HOMOSALATE (HOMOSALATE)	HOMOSALATE	13 g in 100 g
OCTISALATE (OCTISALATE)	OCTISALATE	5 g in 100 g
OCTOCRYLENE (OCTOCRYLENE)	OCTOCRYLENE	2 g in 100 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	4 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
SORBITOL
STEARIC ACID
TROLAMINE
ALUMINUM STARCH OCTENYLSUCCINATE
BENZYL ALCOHOL
SORBITAN ISOSTEARATE
DIMETHICONE
POLYGLYCERYL-3 DIISOSTEARATE
METHYLPARABEN
PROPYLPARABEN
TOCOPHEROL
EDETATE DISODIUM

Packaging
#	Item Code	Package Description
1	NDC:67732-402-16	226 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	11/13/2012

Labeler - DUANE READE INC. (011988995)

Revised: 11/2012

Document Id: a6bb73ff-44fb-48b7-af99-9fb678458c4b

Set id: b6e09f9a-167e-477e-869a-82024c396d32

Version: 1

Effective Time: 20121113

DUANE READE INC.

Daily Med

Current Medication Information

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