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

No7 Rebalancing Day Fluid Sunscreen SPF 15 by

Drug Labeling and Warnings

No7 Rebalancing Day Fluid Sunscreen SPF 15 by is a Otc medication manufactured, distributed, or labeled by BCM Ltd, The Boots Company PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Octinoxate (6.0%)

Avobenzone (2.0%)

Ensulizole (2.0%)

PURPOSE

Purpose

Sunscreens

Uses

• Provides moderate protection against the 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.  If contact occurs, rinse thoroughly with cold water.
• Avoid direct contact with fabrics.
  

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

• 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.
  

STORAGE AND HANDLING

Other information

Do not store above 300C or 860F

INACTIVE INGREDIENT

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.

QUESTIONS

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

DESCRIPTION

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.

INFORMATION FOR PATIENTS

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

DESCRIPTION

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 INGREDIENT

Active Ingredients:

Octinoxate (6.0%)

Avobenzone (2.0%)

Ensulizole (2.0%)

INFORMATION FOR PATIENTS

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

PRINCIPAL DISPLAY PANEL

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

Rebalancing Day Fluid carton.jpg

PRINCIPAL DISPLAY PANEL

No7 Rebalancing Day Fluid

Oily/Combination

Moisturises and mattifies your skin

Sunscreen SPF 15

Hypo-allergenic

Boots

100ml e 3.3 US Fl. Oz

Rebalancing Day Fluid bottle.jpg

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 mL  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mL  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BETAINE (UNII: 3SCV180C9W)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
XANTHAN GUM (UNII: TTV12P4NEE)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLPARABEN (UNII: 14255EXE39)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITOL (UNII: 506T60A25R)
SERINE (UNII: 452VLY9402)
GLYCINE (UNII: TE7660XO1C)
GLUTAMIC ACID (UNII: 3KX376GY7L)
LYSINE (UNII: K3Z4F929H6)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALANINE (UNII: OF5P57N2ZX)
ARGININE (UNII: 94ZLA3W45F)
THREONINE (UNII: 2ZD004190S)
PROLINE (UNII: 9DLQ4CIU6V)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-069-01	1 in 1 CARTON
1		100 mL in 1 BOTTLE, PUMP

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	Business Operations
BCM Ltd		230780322	manufacture, analysis