Label: REAL DEAL FOUNDATION MEDIUM DEEP- titanium dioxide stick

  • 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 November 13, 2011

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  • Active Ingredients

    Octinoxate 7%
    Oxybenzone 3%
    Titanium Dioxide 5%

  • Purpose

    Sunscreen

  • Use

    • Higher SPF gives more sunburn protection.
    • Provides moderate protection against sunburn.
  • Warnings

    For external use only.

    When using this product

    • Keep out of eyes.
    • Rinse with water to remove.

    Stop use and ask a doctor if

    • Rash or irritation develops and lasts.
                   You may report side effect to FDA at 1-800-FDA-1088.

    • Keep out of reach of children.
              If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply evenly before sun exposure as needed.
    • Children under 6 months of age: ask a doctor.
  • Other Information

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • Inactive Ingredients

    Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Silica, Cetyl Dimethicone, Beeswax, Octyldodecyl Neopentanoate, Euphorbia Cerifera (Candelilla) Wax, Propylene Glycol Laurate, Polyethylene, Nylon-12, VP/Hexadecene Copolymer,Octyldodecanol, Ethylhexylglycerin, Cetyl Palmitate, Tocopherol, Tocopheryl Acetate, Ascorbyl Palmitate, Cantella Asiatica Extract, Camellia Sinensis Leaf Extract, Sorbitan Sesquioleate, Water, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol. May Contain: Mica, Titanium Dioxide, Iron Oxides.

  • Questions?

    Call Laura Geller Make-up, Inc., 1(800) MAKE UP4

  • Principal Display Panel

    LAURA GELLER

    BEAUTY INGENUITY

    real deal duo

    Real Deal
    Foundation Stick SPF 15

    Net. Wt. 0.50 oz. / 14.20 g

    &

    Real Deal Concealer

    Net. Wt. 0.70 oz. / 20 g / 16.39 ml

    MEDIUM DEEP
    Real Deal Foundation Stick SPF 15 Medium Deep - Carton
  • INGREDIENTS AND APPEARANCE
    REAL DEAL FOUNDATION  MEDIUM DEEP
    titanium dioxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51389-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51389-111-111 in 1 KIT
    114.20 g in 1 CYLINDER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/13/2011
    Labeler - LAURA GELLER MAKE UP INC. (199474524)
    Establishment
    NameAddressID/FEIBusiness Operations
    MANA PRODUCTS, INC078870292manufacture
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