Label: LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM- avobenzone, octinoxate, octisalate 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 10, 2014

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

  • LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM


    Active Ingredients

    Avobenzone 3.00%
    Octinoxate 7.50%
    Octisalate 5.00%

    Purpose

    Sunscreen

  • USES

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • 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.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • 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.
    • Children under 6 months of age: Ask a doctor.
  • INACTIVE INGREDIENTS

    Water (Aqua), Glycerin, Mica, Octyldodecyl Neopentanoate, Butylene Glycol, Cyclopentsiloxane, Titanium Dioxide (CI 77891), Dimethicone, Camellia Sinensis Leaf Extract, Ginkgo Biloba Leaf Extract, Aloe Barbadensis Leaf Extract, Hamamelis Virginia (Witch Hazel) Water, Centella Asiatica Extract, Lens Esculenta (Lentil) Seed Extract, Dimethiconol, Glyceryl Acrylate/Acrylic Acid Copolymer, PEG/PPG-18 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexandiol, Decylene Glycol, Sodium Hydroxide, Disodium EDTA, Phenoxyethanol, Iron Oxides (CI 77491, CI 77492, CI 77499).

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Questions or comments?

    Call Laura Gellar Beauty, LLC, 1 (800) MAKE UP4

  • LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM 59ml (51389-202-00)

    Drug Facts

    TuscanSunMedium.

  • INGREDIENTS AND APPEARANCE
    LAURA GELLER BEAUTY TUSCAN SUN SPACKLE SPF 30 PROTECTIVE UNDER MAKE-UP PRIMER MEDIUM 
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICA (UNII: V8A1AW0880)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GINKGO (UNII: 19FUJ2C58T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    LENTIL (UNII: 6O38V6B52O)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-202-001 in 1 PACKAGE
    159 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/10/2014
    Labeler - Laura Geller Beauty, LLC (199474524)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA Products, Inc.078870292manufacture(51389-202)