Label: EGF UV SHIELD- oxtinoxate cream

  • 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 December 22, 2019

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

  • Drug Fact

    Active ingredient
    Octinoxate 7.50%
    Octisalate 5.00%
    Zinc Oxide 4.90%
    Titanium Dioxide 4.15%
    Amiloxate 2.00%

    Purpose

    Sunscreen

    Keep out of reach of children

    Stop use and ask a doctor

    if rash or irritation develops and lasts.

    Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away.

    Indication & usage

    Directions
    -Apply generously and evenly 15-20 minutes before sun exposure.

    -Use a water resistant sunscreen if swimming or sweating.

    -Reapply every 1-2 hours after towel drying, swimming or perspiring.

    -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 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 6 months: Ask a doctor

    Warning

    Warnings

    Skin Cancer/Skin Aging Alert:

    Spending time in the sun increases your risk of skin cancer and early skin aging.

    This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use on damaged or broken skin. If sun irritation develops or increases.

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

    Dosage & administration

    for external use only

    Inactive ingredient

    Water, Propylene Glycol, Cyclopentasiloxane, Hydrogenated Poly(C6-14 Olefin Polymer), pentylent glycol, Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Magnesium Sulfate, Disteardimonium Hectorite, Sorbitan Sesquioleate, butylene glycol, Aluminum Hydroxide, Stearic Acid, silica Dimethicone/Vinyl Dimethicone Crosspolymer, Methyl Methacrylate Crosspolymer, caprylyl glycol, tocopheryl acetate, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, jojoba seed oil, ethyhexylglycerin, Aloe Barbadensis Leaf Juice, squalane, sorbitan isostearate, chamomilla recutita (matricaria) flower extract, macadamia ternifolia seed oil, rh-oligopeptide-1, chaenomeles sinensis fruit extract, cinnamomum cassia bark extract, diospyros kaki leaf extract, artemisia princeps leaf extract, sorbitol, camellia sinensis leaf extract, glycerin, chrysanthellum indicum extract, lecithin, glyceryl linoleate, glyceryl linolenate, phenoxyethano, xanthan gum, acetyl hexapeptide-8, sodium ascorbyl phosphate, retinyl palmitate, di-sodium edta, glyceryl caprylate, fragrance

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    EGF UV SHIELD 
    oxtinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58831-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.9 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 100 mL
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIEPOXYCYCLOHEXASILANE (UNII: 066Q83563R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58831-2001-160 mL in 1 TUBE; Type 0: Not a Combination Product07/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/07/2018
    Labeler - Dermaesthetics Inc. (688384549)
    Registrant - Dermaesthetics Inc. (688384549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eyesome Co Ltd557795360manufacture(58831-2001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermaesthetics Inc.688384549relabel(58831-2001)