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Name:No7 Rebalancing Day Fluid Sunscreen Spf 15
Manufacturer:Bcm Ltd
Category:Over-the-counter (OTC) Marketed Drugs


Carton and bottle labelling

NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15  - octinoxate, avobenzone and ensulizole lotion 
BCM Ltd

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 bottle labelling

Active ingredients

Octinoxate (6.0%)

Avobenzone (2.0%)

Ensulizole (2.0%)

Purpose

Sunscreens

Uses

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

Warnings

For external use only

When using this product

  • Keep out of eyes.  If contact occurs, rinse thoroughly with cold water.
  • Avoid direct contact with fabrics.

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

  • After cleansing, massage over your face and neck, avoiding contact with your eyes.
  • Apply evenly at least 15 minutes before sun exposure.
  • Reapply as required.
  • 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, Cyclopentasiloxane, Alcohol denat., Cyclohexasiloxane, C12-15 alkyl benzoate, Triethanolamine, Dimethicone, Acrylamide/ammonium acrylate copolymer, Cetyl alcohol, Myristyl myristate,  C18-36 acid glycol ester, Phenoxyethanol, Lauryl methacrylate/glycol dimethacrylate cross polymer, Polyisobutene, Glyceryl stearate, PEG-100 stearate, Betaine, Parfum (Fragrance), Dimethiconol, Methylparaben, Sodium 2-pyrrolidone-5-carboxylate, Xanthan gum, Ethylparaben, Sodium hyaluronate, Polysorbate 20, Dipropylene glycol, Sorbitol, Tetrasodium EDTA, Serine, Glycine, Glutamic acid, Lysine, BHT, Alanine, Arginine, Threonine, Propylparaben.

USA/Canada: Questions? 1-866-75-BOOTS

Balanced Hydration...

Treat your skin to a long cool drink with this deliciously light lotion, created to work in harmony with oily to combination skin without blocking pores.

The revolutionary water-based formula vanishes in to give your skin just the amount of moisture it needs.  At the same time, the oil-absorbing micro-sponges work to reduce skin oiliness so you look youthfully radiant, not shiny.

With hyaluronic acid to keep skin hydrated for 24 hours, plus our ultra-light SPF 15 to care and protect.

After 2 weeks 68% of our testers said their skin looked healthier and more radiant.

A little facial everyday...

After cleansing, massage over your face and neck.  Apply prior to sun exposure.  Avoid direct contact with eyes.

Dermatologically tested.

Made in the UK

The Boots Company PLC Nottingham England NG2 3AA

Dist in the USA by Boots Retail USA Inc. Stamford CT06901

www.boots.com

Bottle label

Balanced Hydration...

Treat your skin to a long cool drink with this light fluid, created for oily to combination skin without blocking pores.

The water-based formula gives your skin just the amount of moisture it needs. At the same time, the oil-absorbing micro-sponges work to reduce skin oiliness so you look youthfully radiant, not shiny.

With hyaluronic acid to keep skin hydrated for 24 hours.

After 2 weeks 68% of our testers said their skin looked healthier and more radiant.

A little facial everyday...

After cleansing, massage over your face and neck. 

Apply prior to sun exposure.

Avoid direct contact with eyes.

Dermatologically tested.


Active Ingredients:

Octinoxate (6.0%)

Avobenzone (2.0%)

Ensulizole (2.0%)

Made in the UK

The Boots Company PLC Nottingham England NG2 3AA.

Dist in the USA by Boots Retail USA Inc. Stamford CT06901

USA/Canada: Questions? 1-866-75-BOOTS

www.boots.com

Carton label

No7

Rebalancing Day Fluid

Oily/Combination

Moisturises, mattifies and balances your skin

Sunscreen SPF 15

Hypo-allergenic

Boots

100ml e 3.3 US Fl. Oz

../images_otc/no7_rebalanc_Rebalancing Day Fluid carton.jpgRebalancing Day Fluid carton

No7 Rebalancing Day Fluid

Oily/Combination

Moisturises and mattifies your skin

Sunscreen SPF 15

Hypo-allergenic

Boots

100ml e 3.3 US Fl. Oz

../images_otc/no7_rebalanc_Rebalancing Day Fluid bottle.jpgRebalancing Day Fluid bottle


NO7 REBALANCING DAY FLUID SUNSCREEN SPF 15 
octinoxate and avobenzone and ensulizole lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11489-069
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 6 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 2 mL  in 100 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 2 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
CYCLOMETHICONE 5  
CYCLOMETHICONE 6  
TROLAMINE  
DIMETHICONE  
CETYL ALCOHOL  
PHENOXYETHANOL  
GLYCERYL MONOSTEARATE  
BETAINE  
METHYLPARABEN  
SODIUM PYRROLIDONE CARBOXYLATE  
XANTHAN GUM  
HYALURONATE SODIUM  
ETHYLPARABEN  
POLYSORBATE 20  
SORBITOL  
SERINE  
GLYCINE  
GLUTAMIC ACID  
LYSINE  
BUTYLATED HYDROXYTOLUENE  
ALANINE  
ARGININE  
THREONINE  
PROLINE  
PROPYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11489-069-01 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 100 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (11489-069-01)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/04/2009

Labeler - BCM Ltd (230780322)
Registrant - The Boots Company PLC (218622660)
Establishment
Name Address ID/FEI Operations
BCM Ltd 230780322 manufacture, analysis

Revised: 12/2010 BCM Ltd



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


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