NO7 SOFT AND SHEER TINTED MOISTURISER DARK- octinoxate and titanium dioxide emulsion

No7 Soft and Sheer Tinted Moisturiser Dark by

Drug Labeling and Warnings

No7 Soft and Sheer Tinted Moisturiser Dark by is a Otc medication manufactured, distributed, or labeled by Boots Retail USA Inc, The Boots Company PLC, BCM Cosmetique SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                        Purpose

Octinoxate 5%                                Sunscreens

Titanium Dioxide 1.9%

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

Avoid contact with eyes.  If contact occurs rinse immediately with cold water.

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

• Shake before use.
• Smooth on evenly, just like your usual moisturiser.
• 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 300C or 860F

INACTIVE INGREDIENT

Inactive ingredients

Aqua (Water), Glycerin, Butylene glycol, C12-15 alkyl benzoate, Cyclopentasiloxane, Glyceryl stearate, Cetyl alcohol, Dimethicone, Petrolatum, Paraffinum liquidum (Mineral oil), Mica, PEG-100 stearate, Cyclohexasiloxane, C18-36 acid glycol ester, Phenoxyethanol, Methylparaben, Sodium stearoyl lactylate, Polyacrylamide, Alumina, C13-14 isoparaffin, Tetrasodium EDTA, Laureth-7, BHT [+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides).

QUESTIONS

USA: Questions? 1-866-75-BOOTS

INFORMATION FOR PATIENTS

Mfd in France for BBI Ltd NG2 3AA. UK

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

DESCRIPTION

Nicely natural...

Add a little sheer colour while you gently care for your skin, with this soft and silky tinted moisturiser.  It hydrates for 12 hours while light-reflecting particles help smooth the appearance of fine lines and flaws for a natural finish all day long.

Dermatologically Tested

www.boots.com

ACTIVE INGREDIENT

Tube label

Active Ingredients:

Octinoxate 5%

Titanium Dioxide 1.9%

DESCRIPTION

Nicely natural...

Add a little sheer colour while you gently care for your skin, with this soft and silky tinted moisturiser.  It hydrates for 12 hours and evens out your complexion in one simple step, for a natural finish all day long.

With light reflecting particles to help smooth the appearance of fine lines and flaws, plus Sunscreen SPF 15 to help protect your skin from the ageing effects of the sun.

Ready to face the day...

Shake before use.  Smooth on evenly, just like your usual moisturiser.

Dermatologically Tested.

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

No7 Soft and Sheer Tinted Moisturiser

Moisturises, protects and gives you a natural glow

Sunscreen SPF 15

Hypo-allergenic

Boots

50ml e 1.69 US Fl. Oz

Soft and Sheer Tinted Moisturiser carton.jpg

PRINCIPAL DISPLAY PANEL

No7

Soft and Sheet Tinted Moisturiser

All Skin types

Sunscreen SPF 15

Hypo-allergenic

Boots

50ml e 1.69 US Fl. Oz

Soft and Sheer Tinted Moisturiser tube.jpg

INGREDIENTS AND APPEARANCE

NO7 SOFT AND SHEER TINTED MOISTURISER DARK 
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68472-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.5 mL  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.95 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
TALC (UNII: 7SEV7J4R1U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
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: 68472-071-01	1 in 1 CARTON
1		50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/05/2010

Labeler - Boots Retail USA Inc (143151533)

Registrant - The Boots Company PLC (218622660)

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