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Name:No7 Soft And Sheer Tinted Moisturiser Fair
Manufacturer:Boots Retail Usa Inc
Category:Over-the-counter (OTC) Marketed Drugs


Carton and tube labelling

NO7 SOFT AND SHEER TINTED MOISTURISER FAIR  - octinoxate and titanium dioxide emulsion 
Boots Retail USA Inc

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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Carton and tube labelling


Active Ingredients                        Purpose

Octinoxate 5%                                Sunscreens

Titanium Dioxide 1.9%

Uses

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

Warnings

For external use only

When using this product

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

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

Keep out of reach of children.  If swallowed get medical help.

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.

Other information

Do not store above 300C or 860F

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).

USA: Questions? 1-866-75-BOOTS

Mfd in France for BBI Ltd NG2 3AA. UK

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

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

Tube label

Active Ingredients:

Octinoxate 5%

Titanium Dioxide 1.9%

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.

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

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

../images_otc/no7_soft_and_Soft and Sheer Tinted Moisturiser carton.jpgSoft and Sheer Tinted Moisturiser carton

No7

Soft and Sheet Tinted Moisturiser

All Skin types

Sunscreen SPF 15

Hypo-allergenic

Boots

50ml e 1.69 US Fl. Oz

../images_otc/no7_soft_and_Soft and Sheer Tinted Moisturiser tube.jpgSoft and Sheer Tinted Moisturiser tube


NO7 SOFT AND SHEER TINTED MOISTURISER FAIR 
octinoxate and titanium dioxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68472-069
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 2.5 mL  in 50 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.95 mL  in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
BUTYLENE GLYCOL  
C12-15 ALKYL BENZOATE  
CYCLOMETHICONE 5  
GLYCERYL MONOSTEARATE  
CETYL ALCOHOL  
DIMETHICONE  
PETROLATUM  
MINERAL OIL  
POLYOXYL 100 STEARATE  
CYCLOMETHICONE 6  
PHENOXYETHANOL  
METHYLPARABEN  
TALC  
PROPYLPARABEN  
XANTHAN GUM  
ALUMINUM OXIDE  
C13-14 ISOPARAFFIN  
EDETATE SODIUM  
BUTYLATED HYDROXYTOLUENE  
FERRIC OXIDE YELLOW  
FERRIC OXIDE RED  
FERROSOFERRIC OXIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68472-069-01 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 50 mL in 1 TUBE This package is contained within the CARTON (68472-069-01)

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 Operations
BCM Cosmetique SAS 275359578 manufacture

Revised: 03/2010 Boots Retail USA Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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