NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, octisalate, octocrylene

United States - English - NLM (National Library of Medicine)

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Active ingredient:
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Available from:
BCM Ltd
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - helps prevent sunburn
Authorization status:
OTC monograph not final
Authorization number:
11489-149-01

NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM

SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, octisalate, octocrylene cream

BCM Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum

SPF 30

Carton Active Ingredients Section

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 8%

Us es

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), C12-15 alkyl benzoate, Glycerin, Alcohol denat., Tribehenin, Aluminum starch

octenylsuccinate, Butylene glycol, Dimethicone, Cetearyl alcohol, Cetearyl glucoside, Butyrospermum

parkii (Shea) butter, Ammonium acryloydimethyltaurate/VP copolymer, Silica, Phenoxyethanol,

Potassium cetyl phosphate, Methylparaben, Parfum (Fragrance), Propylene glycol, Xanthan gum,

Ethylparaben, Hibiscus abelmoschus extract, Retinyl palmitate, Simethicone, Hydrolyzed hyaluronic

acid, Dipropylene glycol, Hydrolyzed rice protein, Tetrasodium EDTA, Sorbitan laurate, Polysorbate

20, T-butyl alcohol, Sodium lauroyl lactylate, Phyllanthus emblica fruit extract, Carbomer, Calcium

hydroxymethionine, Panax ginseng root extract, 3-aminopropane sulfonic acid, Hydroxyethylcellulose,

Potassium hydroxide, Acetyl dipeptide-1 cetyl ester, Morus alba leaf extract, Ceramide NP, Ceramide

AP, Sodium benzoate, Phytosphingsine, Cholesterol, Ethylhexylglycerin, Tocopherol, Palmitoyl

tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide EOP, CI 77891 (Titanium dioxide), CI 77491 (Iron

oxides), CI 14700 (Red 4).

Des cription

THE BEST OF RESTORE & RENEW COLLECTION

2 x 25 ml e 2 x 0.84 US Fl. Oz.

THE COMPLETE REGIME WILL PROVIDE ESSENTIAL NUTRITION TO HELP YOUR SKIN

LOOK AND FEEL MORE LIKE YOUNG SKIN AGAIN

Made in the UK

The Boots Company PLC

Nottingham England NG2 3AA

Dist. in the USA by Boots Retail USA Inc.

New York NY 10005

www.No7beauty.com

carton

carton

NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM

SUNSCREEN BROAD SPECTRUM SPF 30

avobenzone, octisalate, octocrylene cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:1148 9 -149

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

0 .75 g in 1 g

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

2.0 0 g in 1 g

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

1.25 g in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

CETEARYL GLUCO SIDE (UNII: 0 9 FUA47KNA)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

TRIBEHENIN (UNII: 8 OC9 U7TQZ0 )

AMMO NIUM ACRYLO YLDIMETHYLTAURATE/VP CO PO LYMER (UNII: W59 H9 29 6 ZG)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

SHEA BUTTER (UNII: K49 155WL9 Y)

PO TASSIUM CETYL PHO SPHATE (UNII: 0 3KCY6 P7UT)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

DIMETHICO NO L ( 10 0 0 0 0 CST) (UNII: OSA9 UP217S)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

ETHYLPARABEN (UNII: 14255EXE39 )

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

SO DIUM LAURO YL LACTYLATE (UNII: 7243K8 5WFO)

PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576 )

XANTHAN GUM (UNII: TTV12P4NEE)

HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

TERT-BUTYL ALCO HO L (UNII: MD8 3SFE9 59 )

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

PO TASSIUM HYDRO XIDE (UNII: WZH3C48 M4T)

MO RUS ALBA LEAF (UNII: M8 YIA49 Q2P)

CERAMIDE 3 (UNII: 4370 DF0 50 B)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

PHYTO SPHINGO SINE (UNII: GIN46 U9 Q2Q)

CERAMIDE 6 II (UNII: F1X8 L2B0 0 J)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

CERAMIDE 1 (UNII: 5THT33P7X7)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

BRO WN IRO N O XIDE (UNII: 1N0 32N7MFO)

PALMITO YL TRIPEPTIDE-1 (UNII: RV743D216 M)

PALMITO YL TETRAPEPTIDE-7 (UNII: Q41S46 4P1R)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

ASIAN GINSENG (UNII: CUQ3A77YXI)

ACETYL TYRO SYLARGININE CETYL ESTER (UNII: 3M7W78 X5IR)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SILICO N (UNII: Z4152N8 IUI)

ABELMO SCHUS MO SCHATUS WHO LE (UNII: M7QAW6 6 9 6 G)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

SO RBITAN MO NO LAURATE (UNII: 6 W9 PS8 B71J)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

BCM Ltd

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:1148 9 -149 -0 1

1 in 1 CARTON

0 1/31/20 19

1

25 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 1/31/20 19

Labeler -

BCM Ltd (230780322)

Registrant -

T he Boots Company PLC (218622660)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

BCM Ltd

230 78 0 322

manufacture(1148 9 -149 ) , analysis(1148 9 -149 )

Revised: 8/2019

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