Drug Labeling and Warnings

Drug Details

k">

STUDIO BLEND COVER FOUNDATION SPF 15- studio blend cover 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.

----------

Active Ingredients

titanium dioxide, 6.7%

ethylhexyl methoxycinnamate, 2%

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:

WATER, ISODODECANE, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, PROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, PROPYLENE CARBONATE, DISTEARDIMONIUM HECTORITE, CETYL PEG/PPG-10/1 DIMETHICONE, PEG-10 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, SILICA, METHICONE, DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE, SODIUM CHLORIDE, MAGNESIUM SULFATE, DISODIUM EDTA, MAGNESIUM STEARATE, MAGNESIUM PALMITATE, CI 77492, CI 77499, CI77491

other information:

protect this product from excessive heat and direct sun

questions:

call toll free 1-877-438-1120

71305-500-10

STUDIO BLEND COVER FOUNDATION SPF 15 
studio blend cover foundation spf 15 lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71305-500
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.7 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
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)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MAGNESIUM PALMITATE (UNII: JJ0UR696JR)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71305-500-1035 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201811/01/2020
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: 11/2018
 
Modern Basic Cosmetics Ltd


© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.