Label: NO7 DUAL ACTION TINTED MOISTURISER FAIR- avobenzone, octisalate and octocrylene emulsion

  • 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 December 20, 2019

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

  • active ingredients

    Drug Facts

    Active Ingredients Avobenzone 3%, Octisalate 2%, Octocrylene 4%

    Purpose Sunscreen

  • Purpose section

    Uses

    helps prevent sunburn

  • Warnings.

    Warnings

    For external use only

    Do not use on damaged or broken skin

    When using this product keep out of eyes. Rinse wither water to remove.

  • Ask 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.

  • Indications.

    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 ocntainer from excessive heat and direct sun.

  • Inactives.

    Inactive ingredients

    Aqua (Water), C12-15 alkyl benzoate, Glycerin, Butylene glycol, Cyclopentasiloxane, Mica, Glyceryl stearate, Petrolatum, Paraffinum liquidum (Mineral oil), Dimethicone, Cetearyl alcohol, PEG-100 stearate, Cyclohexasiloxane, Tribehenin, Rosa moschata seed oil, Phenoxyethanol, Alcohol denat., Methylparaben, Sodium stearoyl lactylate, Ascorbyl glucoside, Polacrylamide, Xanthan gum, Ethylparaben, Sodium polacrylate, C13-14 iosparaffin, Sodium hyaluronate, Tetrasodium ETA, Potassium hydroxide, Laureth-7, Dimethylmethoxy chromanol, Phyllanthus emblica fruit extract, Ceramide 3, Ginkgo biloba leaf extract, Ascorbyl palmitate, (+/- (May contain) CI 77891 (Titanium dioxide), CI 77492 (Iron oxides), CI 77491 (Iron oxides), CI 77499 (Iron oxides).

  • Questions.

    USA: Questions? 1-866-75-BOOTS.

  • Description.

    Beautiful Protection.

    Achieve natural, skin perfecting colour with this sheer, light diffusing, tinted moisturiser. It delivers all day hydration and a powerful antioxidant complex to defend your skin from the ageing effects of the sun and the environment.

    For Best Results: Shake well before use. Smooth on evenly, just like your usual moisturiser.

    Hypo-allergenic: Because all skin can have sensitive moments, all our foundation products are hypo-allergenic using ingredients we know and trust.

  • 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.

  • Jar front and active ingredients.

    No7 Dual Action Tinted Moisturiser Sunscreen Broad Spectrum SPF 15

    All skin types

    Long lasting hydration, environmental protection and beautiful sheer colour

    Hypo-allergenic

    50ml 1.6 US Fl Oz

    Active ingredients: Avobenzone 3%, Octisalate 2%, Octocrylene 4%.

  • Warnings.

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

  • Description.

    Beautiful Protection.

    Achieve natural, skin perfecting colour with this sheer, light diffusing tinted moisturiser. It delivers all day hydrtion and a powerful antioxidant complex to defend your skin from the ageing effects of the sun and the environment.

    For Best Results: Shake well before use. Smooth on evenly, just like your usual moisturiser.

  • 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

    CartonN7DATMF

  • INGREDIENTS AND APPEARANCE
    NO7 DUAL ACTION TINTED MOISTURISER FAIR 
    avobenzone, octisalate and octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61589-1911
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1 g  in 50 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MICA (UNII: V8A1AW0880)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHYLLANTHUS EMBLICA FRUIT JUICE (UNII: K8SGU56WPQ)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC FERROCYANIDE (UNII: TLE294X33A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61589-1911-71 in 1 CARTON12/20/2019
    150 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 finalpart35210/29/2012
    Labeler - BCM Cosmetique SAS (275359578)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Cosmetique SAS275359578manufacture(61589-1911)