NO7 STAY PERFECT FOUNDATION SUNSCREEN SPF 15 TRUFFLE 50- octinoxate and titanium dioxide emulsion

No7 Stay Perfect Foundation Sunscreen SPF 15 Truffle by

Drug Labeling and Warnings

No7 Stay Perfect Foundation Sunscreen SPF 15 Truffle 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]

ACTIVE INGREDIENT

Active Ingredients                         Purpose

Octinoxate 5%                               Sunscreens

Titanium Dioxide 1.6%

PURPOSE

Uses

• Provides moderate protection against adverse effects of the sun
• Higher SPF gives more protection
  

WARNINGS AND PRECAUTIONS

Warnings

For external use only

When using this product

Keep out of eyes.  Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

If swallowed get medical help.

INDICATIONS & USAGE

Directions

• Use as a normal foundation
• Apply evenly at least 15 minutes before sun exposure
• Reapply as needed
• Not intended for children under the age of 12
• Not intended for protection while sunbathing
  

STORAGE AND HANDLING

Other information

Do not store above 30oC or 86oF

INACTIVE INGREDIENT

Inactive ingredients

Aqua (Water), Cyclopentasiloxane, Talc, Mica, Ethylhexyl stearate, Cyclohexasiloxane, Dimethicone, Silica, Butylene glycol, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium hectorite, Hexyl laurate, Polyglyceryl-4 isostearate, Dimethicone copolyol, Magnesium sulfate, Phenoxyethanol, Propylene carbonate, Methylparaben, Sodium ascorbyl phosphate, Sodium PCA, Aluminum stearate, Alumina, Tocopheryl acetate, Propylene glycol, Glycerin, Triethoxycaprylylsilane, Sodium lauroyl lactylate, Isopropyl palmitate, Butylparaben, Ethylparaben, Lecithin, Tetrasodium EDTA, Propylparaben, Isobutylparaben, Ceramide 3, BHT, Ceramide 6 II, Cholesterol, Phytosphingosine, Morus alba leaf extract, Carbomer, Xanthan gum, Ceramide 1, [+/1 (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides).

QUESTIONS

Questions? 1-866-75-BOOTS

DESCRIPTION

Staying power...

Discover picture-perfect skin from morning till night, with this stay perfect moisturising foundation.  Soft, silky and flattering in any light, it's rub resistant and won't let you down.  Fragrance free and easy to blend without blocking your pores.

Ready to face the day...

Shake before use.  Dot onto your face and blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face.

Non-pore blocking.

INFORMATION FOR PATIENTS

www.boots.com

Mfd in France for BBI NG2 3AA. UK

Dist in the USA by Boots Retail USA Inc Stamford CT 06901

ACTIVE INGREDIENT

Bottle label

Active Ingredients:

Octinoxate 5%

Titanium Dioxide 1.6%

DESCRIPTION

Discover picture-perfect skin from morning till night, with this stay perfect moisturising foundation.  Soft, silky and flattering in any light, its rub resistant and won't let you down.

Shake well before use.  Blend on smoothly and evenly with your fingers or a sponge.

Non-pore blocking.

INFORMATION FOR PATIENTS

www.boots.com

Mfd in France for BBI Ltd NG2 3AA. UK

Dist in the USA by Boots Retail USA Inc. Stamford CT 06901

USA: Questions? 1-866-75-BOOTS

PRINCIPAL DISPLAY PANEL

Carton label

No7 Stay Perfect

Perfection Continue

Foundation

Fond de Teint

For a long-lasting flawless finish

Sunscreen SPF 15

Hypo-allergenic

Boots

30ml e 1 US Fl. Oz

Stay Perfect Fdn carton.jpg

PRINCIPAL DISPLAY PANEL

Stay Perfect

Foundation

Sunscreen SPF 15

Hypo-allergenic

Boots

30ml e 1 US Fl. Oz

Stay Perfect Fdn bottle labels.jpg

INGREDIENTS AND APPEARANCE

NO7 STAY PERFECT FOUNDATION SUNSCREEN SPF 15 TRUFFLE  50
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61589-1818
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINUM OXIDE (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CHOLESTEROL (UNII: 97C5T2UQ7J)
WHITE MULBERRY (UNII: MN25R0HH5A)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
XANTHAN GUM (UNII: TTV12P4NEE)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61589-1818-1	1 in 1 CARTON
1		30 mL in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/16/2010

Labeler - BCM Cosmetique SAS (275359578)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Cosmetique SAS		275359578	manufacture