BALANCED SATIN FINISH FOUNDATION SPF 15- titanium dioxide, ethylhexyl methoxycinnamate lotion

Balanced Satin Finish Foundation SPF 15 by

Drug Labeling and Warnings

Balanced Satin Finish Foundation SPF 15 by is a Otc medication manufactured, distributed, or labeled by Modern Basic Distributors Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BALANCED SATIN FINISH FOUNDATION SPF 15 
titanium dioxide, ethylhexyl methoxycinnamate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71305-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71305-100-10	1 in 1 BOX	03/01/2017
1		40 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2017

Labeler - Modern Basic Distributors Ltd (208909999)