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

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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FOUNDATION BALANCED SATIN FINISH SPF 15

Active Ingredients

Titanium Dioxide 10%

ethylhexyl methoxycinnamate 2.5%

Purpose

Sunscreen

Keep out of reach of children. If swallowed, get medical help or contact a Poison Centre right away.

Use

•helps prevent sunburn
•if used as directed with other sun protection measures (see Directions), 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.

Directions

•apply liberally 15 minutes before sun exposure
•reapply:
   •after 40 minutes of swimming or sweating
   •immediately after towel drying
   •atleast 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, 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 10 a.m-2 p.m
   •Wear long-sleeved shirts, pants, hats and sunglasses
•children under 6 months of age: Ask a doctor.

Inactive Ingredients

Water, cyclomethicone, butylene glycol, cyclopentasiloxane, peg-10 dimethicone, trimethylsiloxysilicate, dimethicone/vinyl dimethicone crosspolymer, disteardimonium hectorite, silica, sodium chloride, sorbitan sesquioleate, polymethylmethacrylate, tribehenin, phenoxyethanol, xanthan gum, diazolidinyl urea, iodopropynyl butylcarbamate, sodium hyaluronate (CI 77489, 77491, 77492, 77499).

Other Information

Protect this product from excessive heat and direct sun

Questions

Call toll free 1-877-438-1120

Formulated for Professional Application

This carton is made from recycled paper

Cruelty Free - This product has never been tested on animals.

​Made in China

Modern Basic Dist. Ltd. Burnaby BC Canada, Garden Grove CA.

Packaging

FoundationSatin

FOUNDATION BALANCED SATIN FINISH SPF 15 
titanium dioxide, ethylhexyl methoxycinnamate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69349-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
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:69349-103-341 in 1 CARTON11/01/2014
140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2014
Labeler - Modern Beauty Limited (009651789)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou HuaShi Cosmetics Technology CO., Ltd421359948manufacture(69349-103)

Revised: 12/2015
Document Id: dc91b433-59ad-4069-901b-9db24b26dbbe
Set id: f748957e-7ec1-43f4-b9f6-1c45b5ebb126
Version: 1
Effective Time: 20151206
 
Modern Beauty Limited