Label: EGF UV SHIELD- octinoxate cream

  • NDC Code(s): 58831-1001-1, 58831-1001-2
  • 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 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

    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.

    Inactive ingredient

    Water, Propylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hydrogenated Poly(C6-14 Olefin), Cetyl PEG/PPG-10/1 Dimethicone, PEG-10 Dimethicone, Betaine, Disteardimonium Hectorite, Magnesium Sulfate, Sorbitan Sesquioleate, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Portulaca Oleracea Extract, Poncirus Trifoliata Fruit Extract, Tocopheryl Acetate, Sorbitan Isostearate, Squalane, Simmondsia Chinensis(Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Diospyros Kaki Leaf Extract, Cinnamomum Cassia Bark Extract, Artemisia Princeps Leaf Extract, Chrysanthellum Indicum Extract, Chaenomeles Sinensis Fruit Extract, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Chamomilla Recutita(Matricaria) Flower Extract, Lecithin, Sorbitol, Xanthan Gum, Glyceryl Linoleate, Glyceryl Linolenate, rh-Oligopeptide-1, Acetyl Hexapeptide-8, Sodium Ascorbate, Retinyl Palmitate, Phenoxyethanol, Methylparaben, Propylparaben, Butylparaben, Fragrance

  • EGF UV Shield

    EGF UV Shield

    Net WT. 2.03 fl. oz(60ml)

    image of carton label

  • INGREDIENTS AND APPEARANCE
    EGF UV SHIELD 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58831-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 60 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 60 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4.9 g  in 60 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.15 g  in 60 g
    AMILOXATE (UNII: 376KTP06K8) (AMILOXATE - UNII:376KTP06K8) AMILOXATE2 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    BETAINE (UNII: 3SCV180C9W)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PURSLANE (UNII: M6S840WXG5)  
    PONCIRUS TRIFOLIATA FRUIT (UNII: 44445L49J2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SQUALANE (UNII: GW89575KF9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    CHAENOMELES SINENSIS FRUIT (UNII: 6S5Q1Q537Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    SORBITOL (UNII: 506T60A25R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)  
    GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Product Characteristics
    Colorwhite (silver) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58831-1001-21 in 1 BOX12/01/2018
    1NDC:58831-1001-160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/26/2013
    Labeler - Dermaesthetics Inc. (688384549)
    Registrant - Dermaesthetics Inc. (688384549)
    Establishment
    NameAddressID/FEIBusiness Operations
    Eyesome Co Ltd557795360manufacture(58831-1001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermaesthetics Inc.688384549relabel(58831-1001)