Label: URBAN LEGEND ANTIOXIDANT DAY CREAM WITH GREEN TEA AND VITAMIN C 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 October 7, 2019

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

  • Carton

    Active ingredients

    Avobenzone 3%

    Octinoxate 0.5%

    Octisalate 5%

    Octocrylene 7.5%

  • PURPOSE

    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 Doctor section

    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 Centre right away

  • INDICATIONS & USAGE

    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 AND HANDLING

    Other information

    • protect the product in this container from excessive heat and direct sun
    • avoid contact with fabric
  • Inactive ingredients

    Inactive ingredients Aqua (Water), C12-15 alkyl benzoate, Glycerin, Tribehenin, Alcohol denat., Aluminum starch octenylsuccinate, Dimethicone, Cetearyl glucoside, Ammonium acryloldimethyltaurate/VP copolymer, Phenoxyethanol, Potassium cetyl phosphate, Panthenol, Tocopheryl acetate, Polysorbate 20, Dimethiconol, Caprylyl glycol, Ascorbyl glucoside, Sodium benzoate, Bisabolol, Xanthan gum, Ethylhexylglycerin, Parfum (Fragrance), Citric acid, Simethicone, Sphinganine, Tetrasodium EDTA,  Dipropylene glycol, Potassium hydroxide, T-butyl alcohol, Dimethylmethoxy chromanol, Camellia sinensis leaf extract, BHT.

  • Questions

    USA: Questions? 1-866-752-6687

  • Information

    Manufactured for The Boots Company PLC Nottingham England NG2 3AA. Boots Retail Ireland Dublin 12 Ireland.

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

    Made in the UK

    soapandglory.com

  • Description

    Sun Protection and pore-fectly bright skin.  It has to be an...

    This lightweight, non-clogging formula means it's suitable for daily use.  Plus, it contains powerful antioxidants, leaving skin GLORY-ously glowy!

    Enhance the natural radiance of your skin.

    Helps protect your complexion from the sun.

    Double Defence

    Non-clogging

    Sunscreen Broad Spectrum SPF 30

    Dermatologically tested.

    87% of women agreed their skin looked brighter/more radiant after 4 weeks of use.*

    *from user trials conducted on 115 women

    Manufactured for The Boots Company PLC Nottingham England NG2 3AA. Boots Retail Ireland Dublin 12 Ireland.

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

    Made in the UK

    soapandglory.com

  • Tube wording

    Soap & Glory Urban Legend Antioxidant Day Cream with Green Tea and Vitamin C Sunscreen Broad Spectrum SPF 30

    This lightweight, non-clogging formula means it's suitable for daily use. Plus, it contains powerful antioxidants, leaving skin GLORY-ously glowy!

    Enhance the natural radiance of your skin, wh ile helping protect to your complexion from the sun with our double-defence, non-clogging, protecting day cream.

    Every day, apply liberally cheeks, chin & forehead. Using our fingertips, gently blend into the skin making sure every last little bit is covered.

    Warning: Avoid contact with the eyes. If contact with eyes occurs, rinse thoroughly with warm water.  This product is not designed for sunbathing. Avoid contact with fabric.

    Active Ingredients: Avobenzone 3% Octinoxate 0.5% Octisalate 5% Octocrylene 7.5%

    Manufactured for The Boots Company PLC Nottingham England NG2 3AA.  Boots Retail Ireland Dublin 12 Ireland.

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

    Made in the UK

    soapandglory.com

  • Carton

    CartonSGSPF30

  • INGREDIENTS AND APPEARANCE
    URBAN LEGEND ANTIOXIDANT DAY CREAM WITH GREEN TEA AND VITAMIN C SUNSCREEN BROAD SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11489-154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.25 g  in 75 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.375 g  in 75 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.75 g  in 75 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.625 g  in 75 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SPHINGANINE (UNII: YT0ZSD64HM)  
    EDETATE SODIUM TETRAHYDRATE (UNII: L13NHD21X6)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11489-154-011 in 1 CARTON01/01/2020
    175 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 finalpart35201/01/2020
    Labeler - BCM Ltd (230780322)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture(11489-154) , analysis(11489-154)