NO7 BEAUTIFULLY MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 COOL VANILLA- octinoxate and titanium dioxide emulsion

No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla by

Drug Labeling and Warnings

No7 Beautifully Matte Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla by is a Otc medication manufactured, distributed, or labeled by BCM Cosmetique SAS, The Boots Company PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if rash occurs

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

ACTIVE INGREDIENT

Drug Facts

active ingredients octinoxate 5%

Titanium Dioxide 1.6%

purpose sunscreen

INDICATIONS & USAGE

Uses

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

INSTRUCTIONS FOR USE

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

children under 6 months of age ask a doctor

sun protectin measures

spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly 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 am to 2 pm, wear long sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING

protect the product in this container from excessive heat and direct sun

DESCRIPTION

Soft natural matte foundation

Specially created with our patented, fine, oil absorbing powder, this lightweight formulation glides on effortlessly to ensure shine breakthrough is controlled and your colour remains true all day. The unique mattifying formula ensures pores are less visble, whilst Salicylic acid helps fight against bacteria, which cause spots. Also contains our powerful anitoxidant complex and SPF 15 that will help protect against the ageing effects of the sun if the product is used as directed with other sun protection measures. For best results blend smoothly and evenly with your fingers or a sponge. Hypo-allergenic because all skin can have sensitive moments, all our foundation products are hypo-allergenic using ingredients we know and trust.

INACTIVE INGREDIENT

inactive ingredients

aqua (water), cyclopentasiloxane, phenyl trimethicone, alcohol denat, nylon 6/12, glycerin, cyclohexsiloxane, zinc oxide, disteardimonium hectorite, magnesium sulfate, PEG PPG 19/19 dimethicone, tocopheryl acetate, hexyl laurate, polyglyceryl-4- isostearate, propylene carbonate,lauryl methacrylate/glycol dimethacrylate cross polymer, salicylic acid, aluminum hydroxide, phenoxyethanol, lens esculenta fruit extract, stearic acid, triethoxycaprylylsilane, potassium hydroxide, retinyl palmitate, ascorbyl glucoside, tetrasodium edta, isopropyl palmitate, methylparaben, lecithin, ethylparaben, phyllanthus emblica fruit extract, dimethoxyl chromanol, ethylhexylglycerin, ginkgo biloba leaf extract, BHT, tocopherol, may contain CI 77891 (titanium dioxide).

INFORMATION FOR PATIENTS

USA Questions?

1-866-75-BOOTS

The Boots Company PLC

Nottingham England NG2 3AA

Dist by Boots Retail USA Inc

Norwalk CT 06851 USA

Made in France

www.Boots.Com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NO7 BEAUTIFULLY MATTE FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 COOL VANILLA 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61589-6507
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 g  in 30 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.48 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
NYLON-12 (UNII: 446U8J075B)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ZINC OXIDE (UNII: SOI2LOH54Z)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
MAGNESIUM SULFATE (UNII: DE08037SAB)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
METHYLPARABEN (UNII: A2I8C7HI9T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ETHYLPARABEN (UNII: 14255EXE39)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALCOHOL (UNII: 3K9958V90M)
STEARIC ACID (UNII: 4ELV7Z65AP)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61589-6507-1	1 in 1 CARTON
1		30 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/26/2012

Labeler - BCM Cosmetique SAS (275359578)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Cosmetique SAS		275359578	manufacture(61589-6507)