Label: DERMACINRX SKIN MOISTURIZING ULTRA SPF 50 SUNSCREEN- avobenzone, octinoxate, octisalate, titanium dioxide 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 January 11, 2023

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  • 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 finalpart35202/16/2017
    Labeler - PureTek Corporation (785961046)
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