Your browser does not support JavaScript! DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 80 (AVOBENZONE) LOTION [DUANE READE INC.]
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DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 80 (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 3.0 %

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 5.0 %

Oxybenzone 5.0%

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 and 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, Styrene Acrylates Copolymer, Butyloctyl Salicylate, C12-20 Alkyl Glucoside, Caprylyl Glycol, Glycerin, Steareth-20, Polyester-7, Isopropyl Myristate, Steareth-2, Paraffin, Triethanolamine, Neopentyl Glycol Diheptanoate, C14-22 Alcohols, Carbomer, Polysorbate 60, Sodium Lauroyl Sarcosinate, Xanthan Gum, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol, Methylparaben, Propylparaben, Fragrance.

Principal Display Panel

PRevail

moisturizing sunscreen

spf 80

  • antioxidant-enriched
  • uva/uvb protection
  • hypoallergic
  • oil-free

6.5 FL. OZ. (192 mL)ZDR017A0b.jpgZDR017A0f.jpg

DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 80
avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-413
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE5 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE5 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE10 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLOCTYL SALICYLATE  
C12-20 ALKYL GLUCOSIDE 
CAPRYLYL GLYCOL 
GLYCERIN 
STEARETH-20 
POLYESTER-7 
ISOPROPYL MYRISTATE 
STEARETH-2 
PARAFFIN 
TROLAMINE 
NEOPENTYL GLYCOL DIHEPTANOATE 
C14-22 ALCOHOLS 
POLYSORBATE 60 
SODIUM LAUROYL SARCOSINATE 
ALOE VERA LEAF 
XANTHAN GUM 
VITAMIN A PALMITATE 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:67732-413-55184 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
Document Id: d3a81b16-fc04-4d53-8404-346b897baa01
Set id: 9f64a313-cae9-4667-a618-4f106c53e859
Version: 2
Effective Time: 20121114
 
DUANE READE INC.

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