Label: PHOTO DYNAMIC THERAPY SPF 30- avobenzone, octinoxate, octisalate, and oxybenzone lotion

  • 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 9, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Avobenzone 3.0%Sunscreen
    Octinoxate 7.5%Sunscreen
    Octisalate 5.0%Sunscreen
    Oxybenzone 6.0%Sunscreen
  • Use

    Broad spectrum protection

  • Warnings

    • For external use only.

    • UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing and using a sunscreen.
    • Do not get into eyes. Rinse with water to remove.

    • Stop use and consult a doctor if skin rash occurs.

    • Keep out of reach of children.
  • Directions

    Apply daily. Do not seek additional sun exposure. Contains broad spectrum SPF 30. For best results, apply generously 15 minutes prior to sun exposure. Reapply every 2 hours while outdoors. For children under 6 months of age: consult a doctor. Store at room temperature 59-86°F / 15-30°C.

  • Other Ingredients

    Aqua (Water), C12-15 Alkyl Benzoate, Yeast Amino Acids, Polysorbate 20, Glycerin, Butyloctyl Salicylate, Methyl Methacrylate / Glycol Dimethacrylate Crosspolymer, Stearic Acid, Glyceryl Stearate SE, Tricalcium Phosphate, Cyclohexasiloxane, Cyclopentasiloxane, Sorbitan Oleate, Lentinula Edodes (Shiitake Mushroom) Extract, Benzylidene Dimethoxydimethylindanone, Morinda Citrifolia Extract, Camellia Oleifera (Green Tea) Leaf Extract, Camellia Sinensis (White Tea) Leaf Extract, Punica Granatum (Pomegranate) Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Arnica Montana Flower Extract, Anacyclus Pyrethrum Root Extract, Sodium Hyaluronate, Ubiquinone, Tocopherol, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Carbomer, Acrylates / C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Disodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Butylparaben, Propylparaben

  • Questions or Comments?

    ask@DERMAdoctor.com

    www.DERMAdoctor.com®

  • PRINCIPAL DISPLAY PANEL - 30 ml Carton

    PHOTO
    DYNAMIC
    therapy    ™

    sunlight-activated
    laser lotion with
    spf 30

    anti-aging

    DERMAdoctor®

    30 ml – 1 oz e

    Principal Display Panel - 30 ml Carton
  • INGREDIENTS AND APPEARANCE
    PHOTO DYNAMIC THERAPY SPF 30 
    avobenzone, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65113-2432
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    YEAST (UNII: 3NY3SM6B8U)  
    AMINO ACIDS (UNII: 0O72R8RF8A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SHIITAKE MUSHROOM (UNII: 1A64QN2D2F)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ANACYCLUS PYRETHRUM ROOT (UNII: X820IRW34J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Product Characteristics
    ColorYELLOW (Off white to Light yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65113-2432-130 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/01/2010
    Labeler - G.S. COSMECEUTICAL USA, INC. (017014734)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.S. COSMECEUTICAL USA, INC.017014734MANUFACTURE
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