BROAD SPECTRUM SPF 15 PREFERRED PLUS PHARMACY- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
Kinray Inc.

Disclaimer: 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.

----------

Active ingredients

Avobenzone 2.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%, Oxybenzone 5.0%

Uses

Helps prevent sunburn.

Warnings

For external use only.  Do not use on damaged or broken skin. When using this product keep out of eyes.  Rinse with water to remove. Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 15 minutes before sun exposure.  Reapply:  after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. 

Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin again.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:  limit time in the sun, specially from 10am - 2pm, wear long-sleeve shirts, pants, hats, and sunglasses. 

Children under 6 months:  ask a doctor.

Inactive ingredients

Acrylates/C10-30 Alykl Acrylate Crosspolymer, Benzyl Alcohol, Chlorphenesin, Disodium EDTA, Fragrance, Neopentyl Glycol Diheptanoate, Oleth-3, Polyamide-8, Propylene Glycol, Tocopherol, Triethanolamine, Water.

Purpose

Sunscreen.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Preferred Plus Pharmacy

Broad Spectrum SPF 30

Water Resistant (80 Minutes)


label image

BROAD SPECTRUM SPF 15  PREFERRED PLUS PHARMACY
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-024
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE10 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE4 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE5   in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 1342 
BENZYL ALCOHOL 
EDETATE DISODIUM 
NEOPENTYL GLYCOL DIHEPTANOATE 
OLETH-3 
PROPYLENE GLYCOL 
TOCOPHEROL 
TRIETHANOLAMINE BENZOATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:61715-024-08237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/2013
Labeler - Kinray Inc. (012574513)

Revised: 03/2013
Document Id: 83c736e8-381d-4f85-9416-d6585d57fc9f
Set id: 406d0735-a823-4aac-981f-e0efad24abfe
Version: 1
Effective Time: 20130315
 
Kinray Inc.