BALANCED SATIN FINISH FOUNDATION SPF 15 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 Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

titanium dioxide, 10%

ethylhexyl methoxycinnamate, 2.5%

purpose:

- suncreen

- 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

when using:

For external use only
Do not use on damaged or broken skin
Remove with water and mild cleanser

do not use:

- do not use on damaged or broken skin

ask doctor:

- stop use and ask 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 center right away

Directions

*apply liberally 15 minutes before sun exposure
*reapply:
*after 40 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 aging, To decrease risk, regulary 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 10am-2 pm
*wearlong-sleeved shirts, pants, hats and sunglasses
*children under 6 months of age: Ask a doctor

inactive ingredients:

aqua, Cyclopentasiloxane, Disteardimonium Hectorite, Propylene Carbonate, Butylene Glycol, Dimethicone , Dimethicone/
Vinyl Dimethicone Crosspolymer, Trimethylsiloxysilicate, PEG-10 Dimethicone, Sodium Chloride, Silica , Methicone, Polymethyl Methacrylate, Magnesium Stearate, Magnesium Palmitate, Sorbitan Sesquioleate, Lauryl PEG/PPG-18/18 Methicone, Lauryl PEG-9
Polydimethylsiloxyethyl Dimethicone, Disodium EDTA, Sodium Hyaluronate, Xanthan Gum, Tribehenin, Phenoxyethanol, Titanium dioxide, CI 77491, CI 77492, CI 77499, CI 77288, methylisothiazolinone, ethylhexylglycerin

other information:

protect this product from excessive heat and direct sun

questions:

call toll free 1-877-438-1120

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BALANCED SATIN FINISH FOUNDATION SPF 15 
balanced satin finish foundation spf 15 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71305-400
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
METHICONE (20 CST) (UNII: 6777U11MKT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
XANTHAN GUM (UNII: TTV12P4NEE)
CHROMIC OXIDE (UNII: X5Z09SU859)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MAGNESIUM PALMITATE (UNII: JJ0UR696JR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71305-400-10	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2018	11/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/01/2018	11/01/2021

Labeler - Modern Basic Cosmetics Ltd (208909999)