Label: DERMADOCTOR DD EYE SPF30- zinc oxide, titanium dioxide cream

  • 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 June 28, 2021

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  • Active Ingredients

    Titanium Dioxide 3%

    Zinc Oxide 7%

    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 Poinson Control Center right away

  • Directions

    • apply 360 degrees around the eyes twice daily
    • apply lierally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • do not use on children under 6 months.
    • 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 Broad Spectrum SPF value of 15 or higher and other protection measures including
    •  limit time in the sun,especially from 10 a.m.-2 p.m.
    • wear long sleeved shirts, pants, hats and sunglasses
    • reapply at least every 2 hours.
  • Inactive Ingredients

    Albizia Julibrissin Bark Extract, Aloe Barbadensis Leaf Juice, Alumina, Aminomethyl Propanol, Argania Spinosa Kernel Oil, Bisabolol, C12-15 Alkyl Benzoate, Caffeine, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cellulose Gum, Ceramide NG, Cetearyl Alcohol, Citric Acid, Coco-Caprylate, Cocos Nucifera (Coconut) Oil, Darutoside, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Mica, Microcrystalline Cellulose,
    Palmitoyl Hexapeptide-12, Phenoxyethanol, Phytic Acid, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Sodium Stearoyl Lactylate, Stearic Acid, Tocopherol, Tocopheryl Acetate, Tribehenin, Water, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    DD Eye Cream

  • INGREDIENTS AND APPEARANCE
    DERMADOCTOR DD EYE  SPF30
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68715-367
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    zinc oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100.0 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100.0 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)  
    ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAFFEINE (UNII: 3G6A5W338E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DARUTOSIDE (UNII: EG8ODI0780)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    water (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68715-367-021 in 1 CARTON12/01/2018
    1NDC:68715-367-0115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2018
    Labeler - DERMAdoctor (114399392)