Label: NO7 MENOPAUSE SKINCARE PROTECT AND HYDRATE DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, octinoxate, 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 March 1, 2022

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

  • Active Ingredients

    Active ingredients

    Avobenzone 3%

    Octinoxate 0.5%

    Octisalate 5%

    Octocrylene 7.5%

    Purpose

    Sunscreen

  • 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, Dimethicone, Cetearyl glucoside, Ammonium acryloyldimethyltaurate/VP copolymer, Niacinamide, Phenoxyethanol, Potassium cetyl phosphate, Panthenol, Polysorbate 20, Tocopheryl acetate, Parfum (Fragrance), Dimethiconol, Caprylyl glycol, Ascorbyl glucoside, Sodium benzoate, Bisabolol, Xanthan gum, Ethylhexylglycerin, Dipropylene glycol, Citric acid, Sphinganine, Simethicone, Tetrasodium EDTA, Potassium hydroxide, T-butyl alcohol, Dimethylmethoxy chromanol, Camellia sinensis leaf extract, BHT.

  • Description

    All day hydration for dry skin

    CO-CREATED with MENOPAUSAL WOMEN

    Hydrates skin sypically associated with menopause.

    Formulated with SPF to help protect your skin from UV damage and aging.

    Proven to moisturize unbalanced skin, to leave it feeling less dry and sensitive in 1 week.

    Dermatologist approved for menopausal skin.

    Moisturizing Niacinamide

    Hydrating complex

    SPF 30 with Broad Spectrum Protection

    SUITABLE FOR SENSITIVE SKIN

  • INFORMATION FOR PATIENTS

    The Boots Company PLC

    Nottingham England NG2 3AA

    Dist. in the USA by Boots Retail USA Inc. New York NY 10005

    Made in the UK

    www.No7beauty.com

  • Carton

    cartonN7MSDC

  • INGREDIENTS AND APPEARANCE
    NO7 MENOPAUSE SKINCARE PROTECT AND HYDRATE DAY CREAM SUNSCREEN BROAD SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.75 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.25 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SPHINGANINE (UNII: YT0ZSD64HM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ALCOHOL (UNII: 3K9958V90M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-188-011 in 1 CARTON04/01/2022
    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 finalpart35204/01/2022
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-188) , analysis(11489-188)