NO7 RESTORE AND RENEW DAY SUNSCREEN- avobenzone, octisalate, octocrylene cream

No7 Restore and Renew Day Sunscreen by

Drug Labeling and Warnings

No7 Restore and Renew Day Sunscreen 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]

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 Center right away

Directions

Directions for sunscreen use

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 eraly skin aging. Todecrease 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,hates, and sunglasses

Storage

Other information - protect the product in this container from excessive heat and direct sun

Inactive ingredients

Aqua ( Water ), Glycerin, C12-15 alkyl benzoate,Butrospermum parkii (Shea) butter, Isostearyl isostearate, Cyclopentasiloxane, Dimethicone, Cyclohexasiloxane, Glyceryl stearate, Tribehenin, Cetearyl alcohol, PEG-100 stearate, Ammonium acryloydimethyltaurate/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 seed extract, Propylene glycol, carbomer, Potassium hydroxide, Ceramide 3, Ethylhexylglycerin, Polysorbate 20, Ceramide 6 II, Phytosphingosine, Tocopherol, Triethyl citrate, Palmitoyl oligopeptide, Palmitoyl tetrapeptide-7,Ascorbyl palmitate, Ceramide 1, CI 77891 ( Titanium dioxide ),CI 77491 (iron oxides), CI 14700 (Red4)

Description

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 processes.The result is smoother, plumper looking skin that feels firmer and has a renewed healthy glow. Our inensive noursihing complex containing an optimum blend of lipids works to deeply moisturise your skin and help strengthen its resilience to future dryness.

For Best Results: After claensing, simply smooth into your face and neck with your fingertips, avoiding your eyes.

Information

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

Carton Active Ingredients Section

Active Ingredients

Avobenzone 3%

Octisalate 2%

Octocrylene 4%

Purpose Sunscreen

Uses

Uses - helps prevent sunburn

Printed jar

No7 Restore and Renew Day Cream Sunscreen Broad Spectrum SPF 15

50ml e 1.6 US Fl.Oz.

Active ingredients: Avobenzone 3%, Octisalate 2%, Octocrylene 4%

Warning

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

Description

smooth into your face and neck after applying your No7 serum

Information

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

carton

carton

INGREDIENTS AND APPEARANCE

NO7 RESTORE AND RENEW DAY SUNSCREEN 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11489-078
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1 g  in 50 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
SHEA BUTTER (UNII: K49155WL9Y)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLPARABEN (UNII: 14255EXE39)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
EDETATE SODIUM (UNII: MP1J8420LU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CERAMIDE 3 (UNII: 4370DF050B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CERAMIDE 1 (UNII: 5THT33P7X7)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-078-01	1 in 1 CARTON
1		50 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/10/2012

Labeler - BCM Ltd (230780322)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Ltd		230780322	manufacture(11489-078) , analysis(11489-078)