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 canina fruit 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, Ceramide 3, Ethylhexylglycerin, Polysorbate 20, Ceramide 6 ll, Phytosphingosine, Tocopherol, Triethyl citrate, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide 1, CI77891(Titanium dioxide) CI 77491(Iron oxides), CI14700(Red 4)

INFORMATION FOR PATIENTS

The Boots Company PLC Nottingham England NG2 3AA

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

Made in the UK

www.boots.com

Description

Nourishes and revitalises maure skin to reveal younger looking, firmer feeling and more even toned skin in 4 weeks.

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 fimer and has a renewed healthy glow.

Our intensive nourishing complex containing an optimum blend of lipids works to deeply moisturise your skin and help strengthen its resilience to future dryness.

For Best Results:

Carton

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: 11489-109
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 CANINA FRUIT OIL (UNII: CR7307M3QZ)
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)
CERAMIDE 1 (UNII: 5THT33P7X7)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-109-01	1 in 1 CARTON	10/11/2016
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(11489-109) , analysis(11489-109)