NO7 PROTECT AND PERFECT FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CALICO- octinoxate emulsion

No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico by

Drug Labeling and Warnings

No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15 Calico by is a Otc medication manufactured, distributed, or labeled by BCM Cosmetique SAS, The Boots Company PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Carton active ingredient section

Active ingredients Octinoxate 5%

Purpose sunscreen.

Uses

Uses - helps prevent sunburn.
if used with as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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 Centre right away.

Directions

Directions

apply liberally 15 minutes bfore 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

Inactive ingredients

Cyclopentasiloxane, Aqua (Water) Isononyl isononanoate, Glycerin, Silica, Pheny trimethicone, Mica, Dimethicone, Arachidyl propionate, Talc, Titanium dioxide, Disteardimonium hectorite, PEG/PPG-10/1 dimethicone, Alcohol denat., Tocopheryl acetate, Hexyl laurate, Polyglyceryl-4 isostearate, Propylene carbonate, Methylparaben, Ethylparaben, Retinyl palmitate, Ascorbyl glucoside, Lupinus albus seed extract, Carbomer, Dimethylmethoxychromanol, Tetasodium EDTA, Phyllanthus emblica fruit extract, Polysorbate 20, Potasium hyroxide, Ginkgo biloba leaf extract, BHT, Ethylhexylglycerin, Tocopherol, Palmitoyl oligopeptide, Palmitoyl Tetrapeptide-7. May contain CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides).

Description

Renewed radiance.

Gain the immediate appearance of complexion perfection with our light diffusing formula that evens out skin tone. Minimises the appearance of fine lines for younger looking skin. Our Pro-retinol complex containing Lipopeptides boosts and maintain elasticity. Our powerful antioxidant complex and SPF 15 help protect against the ageing effects of free radicals.

For Best Results: Shake before use. Blend smoothly and evenly with your fingers or a sponge, working downwards and outwards from the centre of your face.

Do not store above 30 degrees C or 86 degrees F.

Hypo-allergenic: Because all skin can have sensitive moments all our foundation products are hypo-allergenic so they are kind to even the most sensitive skin.

INFORMATION

The Boots Company PLC

Nottingham

England

NG3 3AA

Dist by Boots Retail USA Inc Norwalk CT 06851 USA

Made in France

www.boots.com.

Bottle label

No7 Protect and Perfect Foundation Sunscreen Broad Spectrum SPF 15

Younger looking skin

Hypo-allergenic 30ml 1 US Fl Oz

Active ingredients

Octinoxate 5%.

Warnings

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

Description

Smoothes and moisturises for younger looking skin and a flawless, radiant complexion.

For Best Results: Shake before use. Blend on smoothly and evenly with your fingers or a sponge.

INFORMATION FOR PATIENTS

The Boots Company PLC Nottingham England NG2 3AA

Dist by Boots Retail USA InC Norwalk CT 06851 USA

Made in France

www.boots.com.

carton label

carton label1

INGREDIENTS AND APPEARANCE

NO7 PROTECT AND PERFECT FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 15 CALICO 
octinoxate emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61589-5313
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.5 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON (UNII: Z4152N8IUI)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
MICA (UNII: V8A1AW0880)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
MAGNESIUM SULFATE (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
LUPINUS ALBUS SEED (UNII: 24GB753W3B)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)
PHYLLANTHUS EMBLICA FRUIT JUICE (UNII: K8SGU56WPQ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61589-5313-1	1 in 1 CARTON
1		30 g in 1 BOTTLE, GLASS

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/29/2012

Labeler - BCM Cosmetique SAS (275359578)

Registrant - The Boots Company PLC (218622660)

Establishment
Name	Address	ID/FEI	Business Operations
BCM Cosmetique SAS		275359578	manufacture(61589-5313)