Duane Reade Prevail Moisturizing Sunscreen Spf 80 (Avobenzone) Lotion [Duane Reade Inc.] -

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 80 (AVOBENZONE) LOTION [DUANE READE INC.]
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NDC	67732-413-55
Set ID	9f64a313-cae9-4667-a618-4f106c53e859
Category	HUMAN OTC DRUG LABEL
Packager	DUANE READE INC.
Generic Name
Product Class
Product Number
Application Number	PART352

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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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67732-413-55	184 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/14/2012

Labeler - DUANE READE INC. (011988995)

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Medic

DUANE READE PREVAIL MOISTURIZING SUNSCREEN SPF 80 (AVOBENZONE) LOTION [DUANE READE INC.]

When using this product

Stop use and ask a doctor if

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