Label: BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15- octinoxate and avobenzone 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 February 24, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients                  Purpose

    Avobenzone 3.0%               Sunscreens

    Octinoxate 6.0%

  • PURPOSE

    Uses

    • Provides moderate protection against the adverse effects of the sun
    • Higher SPF gives more protection
  • WARNINGS AND PRECAUTIONS

    Warnings

    For external use only

    When using this product keep out of eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

  • HOW SUPPLIED

    Colour may vary due to natural extracts

  • ASK DOCTOR

    Stop use and ask a doctor if rash or irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help.

  • INDICATIONS & USAGE

    DIRECTIONS

    • Massage onto face and neck with gentle upward strokes.
    • Apply evenly at least 15 minutes before sun exposure.
    • Reapply as required.
    • Not intended for children under the age of 12.
  • STORAGE AND HANDLING

    Other Information

    Do not store above 300C or 860F

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Aqua (Water), C12-15 alkyl benzoate, Butylene glycol, Glyceryl stearate, PEG-100 stearate, Dimethicone, Cetyl alcohol, Isopropyl myristate, Paraffin, Petrolatum, C18-36 acid glycol ester, Glycerin, Propylene glycol, Punica granatum extract, Phenoxyethanol, Vaccinium myrtillus extract, Mica, Hydroxyethylcellulose, Saccharum officinarum (Sugar cane) extract, Parfum (Fragrance), Xanthan gum, Sodium stearoyl lactylate, Sodium benzoate, Methylparaben, Citrus medica limonum (Lemon) peel extract, Citrus aurantium dulcis (Orange) flower extract, Hibiscus sabdariffa flower extract, Sorbitol, BHT, Tetrasodium EDTA, Butylparaben, Ethylparaben, Acer saccharum (Sugar maple) extract, Dipropylene glycol, Propylparaben, Isobutylparaben, CI 77891 (Titanium dixoide)

  • QUESTIONS

    Questions? 1-866-75-BOOTS

  • DESCRIPTION

    Plant extracts at levels that really work.  Naturally.

    This UVA/UVB balanced SPF 15 moisture cream helps diminish the visible signs of skin ageing by replenishing lost moisture and protecting against environmental damage.  With Hibiscus and Pomegranate extracts to promote skin renewal whilst smoothing away fine lines and wrinkles.

    Dermatologically tested.

  • INFORMATION FOR PATIENTS

    Mfd in the U.K. for BBI NG2 3AA. UK.

    Dist in the USA by Boots Retail USA Inc.

    Stamford CT 06901

    www.boots.com

  • PRINCIPAL DISPLAY PANEL

    Carton label

    FIRST SIGNS OF AGEING

    Face Renewal Cream Sunscreen SPF 15

    Hibiscus brightens

    Pomegranate protects

    PREMIERS SIGNES DU VIEILLISSEMENT

    Crème Régénérante Visage Protection Solaire FPS 15

    L'Hibiscus éclaircit

    La Grenade protège

    Boots

    The Power of Plants

    BOTANICS

    50ml e 1.69 US Fl. Oz

    Face Renewal Cream carton.jpgFace Renewal Cream carton

  • PRINCIPAL DISPLAY PANEL

    Jar front label

    Face Renewal Cream Sunscreen SPF 15

    Crème Régénérante Visage Protection Solaire FPS 15

    Boots

    The Power of Plants

    BOTANICS

    50ml e 1.69 US Fl. Oz

    Face Renewal Cream front label.jpgFace Renewal Cream front label

  • PRINCIPAL DISPLAY PANEL

    Jar back label

    ACTIVE INGREDIENTS/ACTIFS: Octinoxate 6.0%  Avobenzone 3.0%

    WARNINGS: Colour may vary due to natural extracts.

    Sun Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and sunburn.  After use of this product is stopped, use a sunscreen and limit sun exposure for at least a week.

    MISE EN GARDE: La couleur peut varier en raison des extraits naturels.

    Alert Solaire: Ce produit contient un alphahydroxyacide (AHA) qui peut accroître la sensibilité de votre peau et peut provoquer des coupe de soleil. Après avoir cessé d'utiliser ce produit, utilisez un écran solaire et attendez une semaine avant de vous exposure de nouveau.

    Mdf in the U.K. for/Fabriqué au R.-U. pour BBI NG2 3AA. UK.

    Dist in the USA by/aux É.-U. par Boots Retail USA Inc. Stamford CT 06901

    USA/Canada: Questions? 1-866-75-BOOTS

    www.boots.com

    Face Renewal Cream back label.jpgFace Renewal Cream back label

  • INGREDIENTS AND APPEARANCE
    BOTANICS FACE RENEWAL CREAM SUNSCREEN SPF 15 
    octinoxate and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68472-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.0 mL  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 mL  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BILBERRY (UNII: 9P2U39H18W)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LEMON JUICE (UNII: AGN709ANTJ)  
    ORANGE (UNII: 5EVU04N5QU)  
    SORBITOL (UNII: 506T60A25R)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    MAPLE SYRUP (UNII: 75UOH57984)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68472-056-011 in 1 CARTON
    150 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/03/2010
    Labeler - Boots Retail USA Inc (143151533)
    Registrant - The Boots Company PLC (218622660)
    Establishment
    NameAddressID/FEIBusiness Operations
    BCM Ltd230780322manufacture, analysis
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