NO7 EARLY DEFENCE DAY CREAM- avobenzone,octisalate, octocrylene cream

No7 Early Defence Day Cream by

Drug Labeling and Warnings

No7 Early Defence Day Cream 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 5%

Octocrylene 7.5%

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  benzoate,Tribehenin, Alcohol denat, Dimethicone, Aluminum starch octenylsuccinate, Cetearyl glucoside, Butyrospermum parkii(Shea)butter, Ammonium acryloydimethyltaurate/VP copolymer, Phenoxyethanol, Potassium cetyl phosphate, Methylparaben, Parfum(Fragrance), Butylene glycol, Dimethiconol, Propylene glycol, Xanthan gum, Tocopheryl acetate, Ascorbyl glucoside, Ethylparaben, Retinyl palmitate, Hydrolyzed rice protein, Tetrasodium EDTA, T-butyl alcohol, Panax ginseng root extract, Dimethylmethoxy chromanol, Medicago sativa(Alfalfa) extract, Carbomer, Potassium hydroxide, Polysorbate 20, Morus alba leaf extract, Silica, Isopropyl myristate, Sodium benzoate, Tocopherol, Ethylhexylglycerin, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7

Description

Protects and boosts young skin's natural defences to help it look younger for longer.

This super light and non-pore blocking day cream is especially designed for young skin.

Unique Double Defence technology protects skin and boosts natural defences to help it look younger for longer. The protective power of Broad Spectrum SPF30 gives skin advanced protection from the sun and environmental stress. Lipopeptides and Vitamin A help reduce the appearance of first fine lines.

Use every morning after cleansing, massage in small upward circles over face and neck,avoiding the delicate eye area.

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

carton

INGREDIENTS AND APPEARANCE

NO7 EARLY DEFENCE DAY CREAM 
avobenzone,octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11489-097
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 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.75 g  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
XANTHAN GUM (UNII: TTV12P4NEE)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
EDETATE SODIUM (UNII: MP1J8420LU)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
MEDICAGO SATIVA LEAF (UNII: HY3L927V6M)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOMER 940 (UNII: 4Q93RCW27E)
MORUS ALBA LEAF (UNII: M8YIA49Q2P)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11489-097-01	1 in 1 CARTON
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	02/01/2016

Labeler - BCM Ltd (230780322)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Ltd		230780322	manufacture(11489-097) , analysis(11489-097)