Label: PHOTO PLASMA- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 6, 2014

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Titanium dioxide 4.2%

  • Purpose

    Sunscreen

  • Keep out of reach of children

    If swallowed, get medical help or contact a Posion Control Center right away.

  • Uses

    • Helps prevents sun burn
    • 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 extenal 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.

  • Directions 

    • Dr.Perricone recommends applying in the day time as a final and finishing step to any skin care regimen.
    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours.
    • Not for use on Children.
    • 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 sun screen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including
    • limit time in the sun especially from 10 am. - 2 pm.
    • wear long sleaved shirts, Pants, hats and sun glasses
  • Other Information

    • Protect the product from excessive heat and direct sun.
    • Lot number and expiration date -see bottom of the carton
  • Inactive Ingredients

    Aluminum Hydroxide, Astaxanthin, Benzyl alcohol, Bisabolol,Caprylic /Capric Triglyceride, Cyclopentasiloxane, Diethylhexyl Syringy lidenemalonate, Dimethicone, Ethylhexyl Methoxycrylene, Glycerin, Hydrogenated Lecithin, Hydrogenated phosphatidylcholine, Hydroxyethyl Acrylate /Sodium Acrylodimethyl Taurate copolymer, Isohexadecane, Pentylene Glycol, Phenoxyethanol, Polyester-8 ,Polyglyceryl-3 Polydimethylsibxy-ethyl Dimethicone,Polysilicone-11,Polysorbate 60, Potassium Sorbate, Sodium Benzoate, Stearic Acid, Tetrahexyldecyl Ascorbate, Thioctic Acid, Water, Xanthan Gum.

  • SPL UNCLASSIFIED SECTION

    Questions:1 888 823 7837

  • SPL UNCLASSIFIED SECTION

    Distributed by:NV Perricone LLC, Meriden CT 06 450,

    Made in USA

    Distributed by:NV Perricone MD Cosmeceuticals LTD London, WIT 3LN UK

  • Packaging

    Photo Plasma package

  • INGREDIENTS AND APPEARANCE
    PHOTO PLASMA 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61383-201
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61383-201-591 in 1 CARTON
    159 mL in 1 JAR
    2NDC:61383-201-301 in 1 CARTON
    230 mL in 1 JAR
    3NDC:61383-201-151 in 1 CARTON
    315 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2013
    Labeler - Dimensional Merchandising Inc. (076693183)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dimensional Merchandising Inc.076693183manufacture(61383-201)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!