NO7 RESTORE AND RENEW DAY CREAM SPF 15- avobenzone,octisalate, octocrylene cream

No7 Restore and Renew Day Cream SPF 15 by

Drug Labeling and Warnings

No7 Restore and Renew Day Cream 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]

Carton Active Ingredients Section

Active ingredients

Avobenzone 3%

Octisalate 2%

Octocrylene 4%

Uses

Uses - helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

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

Ask a 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

Directions

Directions

Apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use a water resistant sunscreen if swimming or sweating

children 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 10 a.m - 2 p.m.

wear long-sleeved shirts,pants,hats and sunglasses.

Storage

Other information

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

Avoid contact with fabrics

Inactive ingredients

Aqua(Water), Glycerin, C12-15 alkyl bezoate, Butyrospermum parkii (Shea) butter, Isostearyl isostearate, Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Glyeryl stearate, Tribehenin, Cetearyl alcohol, PEG-100 stearate, Ammonium acryloyldimethyltaurate/VP copolymer, Silica, Phenoxyethanol, Myristyl myristate, Rosa moschata seed oil, Dimethiconol, Butylene glycol, Methylparaben, Parfum(Fragrance), Xanthan gum, Ethylparaben, Sodium lauroyl lactylate, Ascorbyl glucoside, Retinyl palmitate, Diospyros kaki calyx extract, Cholesterol, Tetrasodium EDTA, T-butyl alcohol, Lupinus albus seed extract, Propylene glycol, Carbomer, Potassium hydroxide, Ceramide3, Ethylhexylglycerin, Polysorbate 20, Ceramide 6 ll, Phytosphingosine, Tocpherol, Triethyl citrate, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ascorbyl palmitate, Ceramide 1, CI77891(Titanium dioxide) CI 77491(Iron oxides), CI14700(Red 4)

INFORMATION FOR PATIENTS

Made in the UK

The Boots Company PLC Nottingham England NG2 3AA

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

www.boots.com

Description

Restore and Renew Skincare System

A daily skincare regimen to nourish and revitalise mature skin, revealing younger looking, firmer feeling and more even toned skin in just 4 weeks.

Key Ingredients

Matrixyl 3000 and Retinyl Palmitate ( pro-retinol) to help reduce the appearance of wrinkles and provide firmer feeling skin.

Sophora and kiwi extracts to help provide a more even skin tone. Enhanced by a Poly-hydroxyacid in the night serum.

Hyaluronic acid to help moisturise and maintain skin's elasticity.

Ceramide complex, a skin-identical lipid, to help restore the protective barrier function of the skin.

Persimmon Tree extract to help boost skin vitality, for younger looking skin.

Sunscreen Broad Spectrum SPF15 (Day Cream) helps to provide protection against the ageing effects of the sun when used as directed with other sun protection measures.

For best results:

In the morning, smooth Restore and Renew Day Serum onto face and neck with your fingertips, followed by No7 Restore and Renew Day Cream. At night, follow your No7 Restore and Renew Night Serum application with No7 Restore and Renew Night Cream, to help boost the skin's moisture barrier to rejuvenate the look of your skin overnght.

To complete your beauty regimen use No7 Restore and Renew Eye Cream, specially developed for the delicate skin around the eyes to provide day long hydration, revealing smoother skin with a renewed healthy glow.

Day Cream and Night Cream Made in the UK

Day Serum and Night Serum Made in Germany

The Boots Company PLC Nottingham England NG2 3AA

Dist. in the USA by Boots Retail USA Inc.New York NY 10005

www.shopbootsusa.com

Description

No7 Restore and Renew Skincare System

A Daily skincare system with clinically proven serum to provide anti-ageing benefits for mature skin.

Hypoallergenic

No7 Restore and Renew Skincare System contains:

No7 Restore and Renew Day Cream Sunscreen Broad Spectrum SPF 15 50ml   e 1.6 US Fl.Oz

No7 Restore and Renew Night Cream 50ml e 1.6 US Fl.Oz

No7 Restore and Renew Day Serum 15ml e 0.5 US Fl.Oz

No7 Restore and Renew Night Serum 15ml e 0.5 Us Fl. Oz

Description

Clinically proven serum

Visible results

No7 Restore and Renew Day and Night Serum

Clinically proven anti-ageing  benefits for mature skin. Actively targets the 5 key signd of ageing in mature skin to reveal revitalised younger looking skin in just 4 weeks.

Persimmon Tree extract to help boost skin vitality,for younger looking skin

After 4 weeks, skins natural hydration level and youthful radiance are improved, deep lines and wrinkles are less visible, skin feels firmer and looks more evenly toned.

No7 Restore and Renew Skincare System

Experience a range formulated to work even better together to reveal revitalised younger looking skin.

No7 Restore and Renew Skincare System

A Daily skincare regimen to nourish and revitalise mature skin, revealing younger looking, firmer feeling and more toned skin in just 4 weeks.

No7 Restore and Renew Day and Night Serum

Clinically proven day and night serum helps skin appear strengthened to reveal youthful radiance. This powerful duo works together to effectively target 5 key signs of ageing in mature skin:

1. Lines and wrinkles, 2.lack of firmness, 3.uneven skin tone, 4.fragility, 5.dullness.

For best results: Smooth the day serum onto your face and neck every morning. Smooth the night serum onto your face and neck every morning. Follow with your Restore and Renew Day or Night Cream.

No7 Restore and Renew Day Cream Sunscreen Broad Spectrum SPF15

Nourish and revitalise your skin with this protecting and replenishing daytime formula. Created to provide day long hydration,replenish lost lipids and help boost your skin's repair and recovery process. Formulated with Sunscreen Broad Spectrum SPF15 to help provide protection from the ageing effects of the sun. The result is smoother, plumper looking skin that feels firmer and has a renewed healthy glow.

For best results: Use in the morning after cleansing and applying Restore and Renew Day Serum. Simply smooth onto yourface and neck with your fingertips, avoiding your eye area.

No7 Restore and Renew Night Cream

Nourish and revitalise your skin with this replenishing night time formula. Created to replenish lost lipids and help boost the skin's moisture barrier to rejuvenate the look of our skin overnight. Helps boost your skin's resilience to environmental stress and the result is smoother, plumper looking skin that feels firmer.

For best results: Use just before bedtime, after cleansing the skin and applying Restore and Renew Night Serum. Smooth onto your face and neck with your fingertips, avoiding your eye area.

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

NO7 RESTORE AND RENEW DAY CREAM SPF 15 
avobenzone,octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11489-098
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 50 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SHEA BUTTER (UNII: K49155WL9Y)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
METHYLPARABEN (UNII: A2I8C7HI9T)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
ETHYLPARABEN (UNII: 14255EXE39)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
EDETATE SODIUM (UNII: MP1J8420LU)
CHOLESTEROL (UNII: 97C5T2UQ7J)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
LUPINUS ALBUS SEED OIL (UNII: 958BJW095Q)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER 940 (UNII: 4Q93RCW27E)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
TOCOPHEROL (UNII: R0ZB2556P8)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CERAMIDE 1 (UNII: 5THT33P7X7)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-098-01	1 in 1 CARTON	05/02/2016
1		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/16/2016

Labeler - BCM Ltd (230780322)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Ltd		230780322	manufacture(11489-098) , analysis(11489-098)