Label: EGF FGF DNA UV SHIELD- ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate cream

  • NDC Code(s): 58831-1100-1, 58831-1100-2
  • Packager: Dermaesthetics Inc.
  • 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 October 5, 2021

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

  • ACTIVE INGREDIENTS

    Ethylhexyl Methoxycinnamate 5.40%
    Titanium Dioxide 5.00%
    Ethylhexyl Salicylate 3.40%

  • INACTIVE INGREDIENTS

    Aqua, Cyclopentasiloxane,Propylene Glycol, Silica, 4-Methylbenzylidene Camphor, Cyclohexasiloxane, Cetyl Ethylhexanoate, Sorbitan Isostearate, Glycerin, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetyl PEG/PPG-10/1 Dimethicone, Sodium Chloride, Calcium Stearate, Dimethicone, Betaine, Beeswax, Allantoin, Ozokerite, Butylene Glycol, Aloe Barbadensis Leaf Juice Powder, Triethoxycaprylylsilane, Xanthan Gum, 1,2-Hexanediol, Sodium DNA, Ginkgo Biloba Leaf Extract, Ethylhexylglycerin, Lecithin, Polysorbate 20, sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-1, sh-Oligopeptide-1

  • PURPOSE

    Sunscreen

  • WARNINGS

    FOR EXTERNAL USE ONLY
    Do not use on Stop use and ask a doctor if
    ■ on damaged or broken skin. ■ rash occurs.

    When using this product
    ■ keep out of eyes. Rinse with water to remove.

  • DESCRIPTION

    Uses:

    ■ Helps prevent sun burn
    ■ 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.

    Directions:

    For sunscreen use:
    ■ apply generously and evenly 15 minutes before sun exposure.
    ■ apply to all skin exposed to the sun.
    ■ children under 6 months of age: Ask a doctor.
    ■ 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    ■ limit time in the sun, especially from 10a.m-2p.m.
    ■ wear long sleeve shirts, pants, hats, and sunglasses.
    ■ reapply at least every 2 hours
    ■ use a water resistant sunscreen if swimming or sweating

  • Other Information

    ■ Protect this product in this container from excessive heat and direct sun.

  • Questions or Comments?

    (213) 545-1266 / DERMAESTHETICSUSA.COM

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    EGF FGF DNA UV SHIELD 
    ethylhexyl methoxycinnamate, titanium dioxide, ethylhexyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58831-1100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.24 g  in 60 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide3.0 g  in 60 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.04 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58831-1100-21 in 1 CARTON10/01/2021
    1NDC:58831-1100-160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2021
    Labeler - Dermaesthetics Inc. (688384549)
    Registrant - Dermaesthetics Inc. (688384549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aqualex687515213manufacture(58831-1100)