BALANCED SATIN FINISH FOUNDATION SPF 15- titanium dioxide, ethylhexyl methoxycinnamate lotion 
Modern Basic Distributors Ltd

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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balanced satin finish foundation SPF 15

active ingredients

titanium dioxide 10%

ethylhexyl methoxycinnamate 2.5%

purpose

sunscreen

use:

•helps prevent sunburn

•if used as directed with other sun protection measures (see directions),it decreases the risk of skin cancer and early skin aging caused by the sun

warnings:

for external use only

do not use on damaged or broken skin

when using this product keep out of eyes

remove with water and mild cleanser

stop use and ask a doctor if rash occurs

keep out of reach of children. if swallowed, get medical help or contact a poison control centre right away

directions:

•apply liberally 15 minutes before sun exposure

•reapply after 40 minutes of swimming or sweating

•reapply immediately after towel drying

•reapply at least every 2 hours

sun protection measures:

spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including:

•limit time in the sun, especially from 10 am to 2 pm

•wear long-sleeved shirts, pants, hats, and sunglasses

•children under 6 months of age: ask a doctor

inactive ingredients

water, cyclopentasiloxane, butylene glycol, trimethylsiloxysilicate, PEG-10 dimethicone, silica, methicone, polymethyl methacrylate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, lauryl PEG/PPG-18/18 methicone, sorbitan sesquioleate, disteardimonium hectorite, propylene carbonate, tribehenin, xanthan gum, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, sodium hyaluronate, magnesium stearate, sodium chloride, phenoxyethanol, ethylhexylglycerin, methylisothiazolinone, parfum, CI 77489, CI 77491, CI77492, CI 77499.

other information:

protect this product from excessive heat and direct sun

questions:

call toll free 1-877-438-1120

Dist. by/Par: Modern Basic, Burnaby, BC/

Garden Grove, CA. 

Formulated for professional application.

this carton is made from recycled paper 

cruelty free - this product is not tested on animals

Made in Canada

Packaging

image description

BALANCED SATIN FINISH FOUNDATION SPF 15 
titanium dioxide, ethylhexyl methoxycinnamate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71305-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
FERROUS OXIDE (UNII: G7036X8B5H)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71305-100-101 in 1 BOX03/01/2017
140 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2017
Labeler - Modern Basic Distributors Ltd (208909999)

Revised: 4/2017
Document Id: 575e5862-5f20-4fec-98eb-658c4538ba66
Set id: 63bd03ad-0aab-445d-a1e6-548eb3d52ebf
Version: 1
Effective Time: 20170407
 
Modern Basic Distributors Ltd