NO7 PROTECT AND PERFECT DAY SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, octinoxate, octisalate cream

No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

No7 Protect and Perfect Day Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Boots Retail USA Inc, The Boots Company PLC, BCM Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Avobenzone (3.0%), Octinoxate (6.0%), Octisalate (2.5%)

Purpose Sunscreen

PURPOSE

Uses helps prevent sunburn

WARNINGS AND PRECAUTIONS

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out if eyes. Rinse with water to remove.

ASK DOCTOR

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Directons

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Chidren under 6 months of age: Ask a doctor

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:

limit time in the sun, especially from 10a,m - 2p.m

wear long-sleeved shirts, pants, hat and sunglasses

STORAGE AND HANDLING

Other information

Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredients

Aqua (water), Glycerin, C12-15 alkyl benzoate, Butyrospermum parkii (shea) butter, Dimethicone, Isononyl isonanoate, Cetearyl alcohol, C18-36 acid glycol ester, Polyglyceryl-3-methylglucose distearate, Phenoxyethanol, Polyacrylamide, Sorbitan stearate, Mica, Polysorbate 20, Alcohol denat., Methylparaben, Potassium cetyl phosphate, Ethylparaben, Parfum (fragrance), Laureth-7, Retinyl palmitate, Sucrose cocoate, Dipropylene glycol, Xanthan gum, ascorbyl glucoside, Tetrasodium EDTA, Citric acid, Lupinus albus seed extract, Dimethylmethoxy chromanol, Carbomer, Phyllanthus emblica fruit extract, Potassium hydroxide, Ginkgo biloba leaf extract, BHT, Tocopherol, Butylparaben, Palmitoyl oligopeptide, Propylparaben, Isobutylparaben, Palmitoyl tetrapeptide-7, CI 77891 (Titanium dioxide)

QUESTIONS

USA: Questions? 1-866-75-BOOTS

DESCRIPTION

Smooth fine lines and help delay new ones with this protecting  and revitalising daytime formula, your first defence against the early signs of ageing. Created to be used with our protect and pefect serum to help deliver even better results that the serum alone.

INFORMATION FOR PATIENTS

Hypoallergenic

The Boots company PLC Nottingham England NG2 3AA

Dist. by Boots Retail USA Inc. Norwalk CT 06851 USA

Made in the UK
www.Boots.com/no7

DESCRIPTION

For best results use every morning after cleansing and applying protect and perfect serum. Simply smooth into our face and neck with your fingertips, avoiding your eyes.

With our firming pro-retinol complex containing lipopeptides to help boost and maintain elasticity.

ACTIVE INGREDIENT

JAR TEXT

Active ingredients: Octinoxate 6%, Avobenzone 3%, Octisalate 2.5%

WARNINGS

JAR TEXT

Warning: Avoid contact with eyes. If product gets into the eyes rinse well with water immediately.

INDICATIONS & USAGE

JAR TEXT

Smooth into your face and neck after applying your No7 serum.

INFORMATION FOR PATIENTS

JAR TEXT

The Boots Company PLC Nottingham England NG2 3AA

Dist. in the USA by Boots Retail USA Inc. Norwalk CT 06851 USA

Made in the UK
www.Boots.com/no7

PRINCIPAL DISPLAY PANEL

No7 Protect and Perfect

Day Cream

Protects young skin to delay the appearance of fine lines

Sunscreen broad spectrum SPF 15

50ml 1.6US Fl.Oz

P and P Day Cream carton.jpg

PRINCIPAL DISPLAY PANEL

JAR TEXT

No7 Protect and Perfect Day Cream

Hypo-allergenic

Sunscreen Broad Spectrum SPF 15

50ml 1.6 US Fl.Oz

P and P Day Cream jar.jpg

INGREDIENTS AND APPEARANCE

NO7 PROTECT AND PERFECT DAY SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68472-109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	1.5 mL  in 50 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	3 mL  in 50 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	1.25 mL  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SHEA BUTTER (UNII: K49155WL9Y)
Dimethicone (UNII: 92RU3N3Y1O)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
mica (UNII: V8A1AW0880)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALCOHOL (UNII: 3K9958V90M)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYLPARABEN (UNII: A2I8C7HI9T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ETHYLPARABEN (UNII: 14255EXE39)
LAURETH-7 (UNII: Z95S6G8201)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SUCROSE COCOATE (UNII: 3H18P0UK73)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
XANTHAN GUM (UNII: TTV12P4NEE)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
EDETATE SODIUM (UNII: MP1J8420LU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LUPINUS ALBUS SEED (UNII: 24GB753W3B)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GINKGO (UNII: 19FUJ2C58T)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68472-109-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2012

Labeler - Boots Retail USA Inc (143151533)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Ltd		230780322	manufacture, analysis