BROAD SPECTRUM SPF 15 PREFERRED PLUS PHARMACY- avobenzone, homosalate, octisalate, octocrylene 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.

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Drug Facts

Active ingredients
<Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 5%>

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, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Carbomer, Cetyl Phosphate, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Sorbitol, 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 15

Water Resistant (80 Minutes)

Label image

BROAD SPECTRUM SPF 15  PREFERRED PLUS PHARMACY
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER 1342 (UNII: 809Y72KV36)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SORBITOL (UNII: 506T60A25R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-023-08237 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: 3/2013
Document Id: e0b2e235-9b25-462f-8b3d-6d668db6b053
Set id: d6958759-73aa-4841-96f1-47943bb29c74
Version: 1
Effective Time: 20130315
 
Kinray Inc.