BROAD SPECTRUM SPF 50 BABY SUNSCREEN 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.

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Active ingredients

Avobenzone 3.0%, Homosalate 13.0%, Octisalate 5.0%, Octocrylene 7.0%, Oxybenzone 4.0%

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

Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone, Disodium EDTA, Fragrance, Methylparaben, Polyglceryl-3 Distearate, Propylparaben, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, 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 50

Baby Sunscreen Lotion

Water Resistant (80 Minutes)

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BROAD SPECTRUM SPF 50 BABY SUNSCREEN  PREFERRED PLUS PHARMACY
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 g  in 100 mL
HOMOSALATE (HOMOSALATE) HOMOSALATE13 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE7 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE 
BENZYL ALCOHOL 
CARBOMER 940 
DIMETHICONE 
EDETATE DISODIUM 
METHYLPARABEN 
POLYGLYCERYL-3 DISTEARATE 
PROPYLPARABEN 
SORBITAN ISOSTEARATE 
SORBITOL 
STEARIC ACID 
TOCOPHEROL 
TRIETHANOLAMINE BENZOATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:61715-027-08237 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: 49e59084-6f17-4940-8f7d-55c9c17b6a1c
Set id: 7c29c3d5-a4fe-4d0f-8a93-fe4ecfc502f5
Version: 1
Effective Time: 20130315
 
Kinray Inc.