DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 80- avobenzone lotion

Duane Reade Prevail Moisturizing Sunscreen by

Drug Labeling and Warnings

Duane Reade Prevail Moisturizing Sunscreen by is a Otc medication manufactured, distributed, or labeled by DUANE READE INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

DUANE READE PREVAIL MOISTURIZING SUNSCREEN  SPF 80
avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67732-413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
STEARETH-20 (UNII: L0Q8IK9E08)
POLYESTER-7 (UNII: 0841698D2F)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARETH-2 (UNII: V56DFE46J5)
PARAFFIN (UNII: I9O0E3H2ZE)
TROLAMINE (UNII: 9O3K93S3TK)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
C14-22 ALCOHOLS (UNII: B1K89384RJ)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XANTHAN GUM (UNII: TTV12P4NEE)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67732-413-55	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)