Drug Labeling and Warnings

Drug Details

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BALANCED SATIN FINISH FOUNDATION SPF 15- balanced satin finish foundation spf 15 lotion 
Modern Basic Cosmetics 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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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

BALANCED SATIN FINISH FOUNDATION SPF 15 
balanced satin finish foundation spf 15 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71305-400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71305-400-1040 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/201811/01/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/201811/01/2020
Labeler - Modern Basic Cosmetics Ltd (208909999)

Revised: 10/2018
 
Modern Basic Cosmetics Ltd


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