Label: DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN- avobenzone, octinoxate, octisalate, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 2, 2024

If you are a consumer or patient please visit this version.

  • Active ingredients (% w/w)

    Avobenzone 2.5%

    Octinoxate 3%

    Octisalate 3%

    Titanium Dioxide 1.25%

  • Purposes

    Sunscreen (Avobenzone 2.5%)
    Sunscreen (Octinoxate 3%)
    Sunscreen (Octisalate 3%)
    Sunscreen (Titanium Dioxide 1.25%) 

  • Uses

    ■ Helps prevent sunburn.

    ■ If used as a directed with other sun protection measures (see Directions), decreases the risk of 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 Poison Control Center right away.

  • Directions

    ■ Apply liberally 15 minutes before sun exposure ■ Use a water-resistant sunscreen if swimming or sweating or immediately after towel drying   
    ■ Reaply: ■ at least every 2 hours. ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: ■ Limit time in the sun, especially from 10 a.m. - 2 p.m. ■ Wear long-sleeve shirts, pants, hats, and sunglasses. ■ Children under six months of age: Ask a doctor.

  • Inactive ingredients

    Water, Emulsifying Wax, Shea butter, Stearic Acid, Ethylhexyl Palmitate, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Sunflower Seed Oil, Isopropyl Isostearate, Vitamin E, Potassium Sorbate, Xanthan Gum, Sodium Benzoate.

  • Other information

    ■ Protect this product from excessive heat and direct sun

  • Questions?

    1.800.611.4270 

  • Dermacin ®Rx Skin Moisturizing Ultra SPF 50 Sunscreen Lotion (Label)

    DISTRIBUTED BY:

    PureTek Corporation
    San Fernando, CA 91340

    image description

  • INGREDIENTS AND APPEARANCE
    DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN 
    avobenzone, octinoxate, octisalate, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-568
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE12.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-568-0556 mL in 1 BOTTLE; Type 0: Not a Combination Product02/16/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/16/2017
    Labeler - PureTek Corporation (785961046)