Label: MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED SPF 28 BROAD SPECTRUM- zinc oxide and 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 February 25, 2019

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Zinc Oxide (ZinClear™)11.6%
    PurposeSunscreen
    Titanium Dioxide0.67%
    PurposeSunscreen
  • 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.
  • 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 and irritation develops and lasts.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • For daily use, allow product to absorb completely before applying make-up.
    • Apply liberally 15 minutes before sun exposure.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply 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 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.
  • Inactive Ingredients

    1,2-Hexanediol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-beta), Gluconolactone, Glycerin, Glyceryl Isostearate, Glycine Soja (Soybean) Oil, Isononyl Isononanoate, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Aluminum Silicate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Polysorbate 60, Populus Tremuloides Bark Extract, Potassium Sorbate, Simethicone, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine Disuccinate, Tropolone, Xanthan Gum

  • Other Information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

    SUN
    PROTECTION

    Sun Shield
    Unscented
    SPF 28
    Broad Spectrum

    REEF
    SAFE

    MyChelle®
    dermaceuticals

    2.3 fl oz / 68 mL

    PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED   SPF 28 BROAD SPECTRUM
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide11.6 g  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.67 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Squalane (UNII: GW89575KF9)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Allantoin (UNII: 344S277G0Z)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Tropolone (UNII: 7L6DL16P1T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-060-681 in 1 BOX11/01/2017
    168 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35211/01/2017
    Labeler - French Transit, Ltd. (100044380)
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