Your browser does not support JavaScript! DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30 (AVOBENZONE) LOTION [DUANE READE INC.]
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DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 30 (avobenzone) lotion
[DUANE READE INC.]


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

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)ZDR015A0f.jpgZDR015A0b.jpg

DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 30
avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67732-411
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE1 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE4.5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67732-411-55184 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/14/2012
Labeler - DUANE READE INC. (011988995)

Revised: 11/2012
 
DUANE READE INC.

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