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

FOUNDATION BALANCED SATIN FINISH SPF 15 by

Drug Labeling and Warnings

FOUNDATION BALANCED SATIN FINISH SPF 15 by is a Otc medication manufactured, distributed, or labeled by Modern Beauty Limited, Guangzhou HuaShi Cosmetics Technology CO., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 10%

ethylhexyl methoxycinnamate 2.5%

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69349-103
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 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69349-103-34	1 in 1 CARTON	11/01/2014
1		40 mL in 1 CONTAINER; 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	11/01/2014

Labeler - Modern Beauty Limited (009651789)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou HuaShi Cosmetics Technology CO., Ltd		421359948	manufacture(69349-103)