Label: DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 7, 2016

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  • Active Ingredients

    Titanium Dioxide 3.30%

    Zinc Oxide 12.05%

  • Use

    • 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 docor if rash occurs
    • Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use water resistant sunscreen if swimming or sweathing
    • Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.
    • Children under 6 months: ask a doctor
  • Inactive Ingredients

    Alumina, Aluminum Hydroxide, Behenyl Alcohol, Butylene Glycol, C12-15 Alkyl Benzoate, Caprylic/Capric/Myristic/Stearic Triglyceride, Caprylyl Glycol, Carbomer, Cellulose Gum, Cety Alcohol, Dextrin Palmitate, Dimethicone, Dimethylacrylamide/Acrylic Acid/Plystyrene Ethyl Methacylate, Disodium EDTA, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrogenated Lecithin, Isostearic Acid, Lycium Barbarum Fruit Extract, Lysine, Magnesium Chloride, Nordihydroguaiaretic Acid, Octyldodecyl Neopenanoate, Oleanolic Acid, Palmitoyl Hexapeptide-14, Panthenol, PEG-60 Almond Glycerides, Phenoxyethanol, Phospholipids, Phytantriol, Polygleceryl-3 Diisostearate, Polysorbate 80, Potassium Chloride, Silica, Sodium Benozate, Sodium Chloride, Sodium Dehydroacetate, Sodium Hyaluronate Crosspolymer, Sodium Hydroxide, Squalane, Steareth-2, Steareth-21, Stearic Acid, Superoxide Dismutase, Tetrahexyldecyl Ascorbate, Tocopherol, Tocopheryl Acetate, Triethoxycaprylylsilane, Triethylhexanoin, Water, Xanthan Gum, Zinc Chloride May Contain (+/-): Mica, Iron Oxides.

  • Other Information

    • Protect this product form excessive heat and direct sun
  • Principal Display Panel

    59735-150

  • INGREDIENTS AND APPEARANCE
    DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 
    dermadoctor dd cream dermatologically defining bb cream broad spectrum spf 30 lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59735-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.05 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM (UNII: CPD4NFA903)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C12-15 ALCOHOLS (UNII: 2C8M6XLB5C)  
    CAPRYLIC/CAPRIC/PALMITIC/STEARIC TRIGLYCERIDE (UNII: ZF29F7IK5I)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALPHA CELLULOSE (UNII: I355QGZ19A)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    2,3-DIMETHYLACRYLIC ACID, (E)- (UNII: I5792N03HC)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    LYSINE (UNII: K3Z4F929H6)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    OLEANOLIC ACID (UNII: 6SMK8R7TGJ)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SILICON (UNII: Z4152N8IUI)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    SQUALANE (UNII: GW89575KF9)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUPEROXIDE DISMUTASE (CU-ZN) SACCHAROMYCES CEREVISIAE (UNII: ZQP6EKT6WD)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59735-150-0140 g in 1 TUBE; Type 0: Not a Combination Product12/07/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/07/2016
    Labeler - Mana Products (078870292)