Your browser does not support JavaScript! DUANE READE SUNSCREEN SPF 50 (AVOBENZONE) LOTION [DUANE READE INC.]
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DUANE READE SUNSCREEN SPF 50 (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 13.0%

Octisalate 5.0%

Octocrylene 7.0%

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 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.

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

sunscreen

50

SPF

moisturizing lotion

Broad Spectrum Protection

Very Water Resistant


8 FL OZ (237 mL)ZDR001B0.jpg

DUANE READE SUNSCREEN  SPF 50
avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-403
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 g
HOMOSALATE (HOMOSALATE) HOMOSALATE13 g  in 100 g
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE7 g  in 100 g
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
STEARIC ACID 
TROLAMINE 
ALUMINUM STARCH OCTENYLSUCCINATE 
BENZYL ALCOHOL 
SORBITAN ISOSTEARATE 
DIMETHICONE 
POLYGLYCERYL-3 DIISOSTEARATE 
METHYLPARABEN 
PROPYLPARABEN 
TOCOPHEROL 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:67732-403-16226 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/13/2012
Labeler - DUANE READE INC. (011988995)

Revised: 11/2012
Document Id: ac3a3820-715e-4fb8-ba00-387c02eeabae
Set id: fa604ecb-fe79-4779-bd81-9c3e60a24dcb
Version: 1
Effective Time: 20121113
 
DUANE READE INC.

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