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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated January 31, 2019

If you are a consumer or patient please visit this version.

  • Carton Active Ingredients Section

    Active ingredients

    Avobenzone 3%

    Octisalate 5%

    Octocrylene 8%

  • 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), 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).

  • Description

    RESTORE & RENEW MULTI ACTION FACE & NECK COLLECTION

    25 ml e 0.84 US Fl.Oz.

    The complete anti-aging skincare regime to reveal a firmer feeling, smoother, more even and younger looking face & neck in 4 weeks.

  • INFORMATION FOR PATIENTS

    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

    cartonRRMAFNMD2019frontRRMAFNMD2019back

  • INGREDIENTS AND APPEARANCE
    NO7 RESTORE AND RENEW FACE AND NECK MULTI ACTION DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30 
    avobenzone, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.75 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.00 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.25 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CERAMIDE 6 II (UNII: F1X8L2B00J)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR)  
    ALCOHOL (UNII: 3K9958V90M)  
    SILICON (UNII: Z4152N8IUI)  
    ABELMOSCHUS MOSCHATUS WHOLE (UNII: M7QAW6696G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-144-011 in 1 CARTON01/31/2019
    125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/31/2019
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-144) , analysis(11489-144)