Label: MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 UNSCENTED PROTECT- 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 January 6, 2022

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Zinc Oxide11.6%
    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

    • SHAKE WELL BEFORE USE.
    • For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
    • 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

    MyCHELLE®
    DERMACEUTICALS

    PROTECT

    Sun Shield SPF 28
    Unscented

    Broad-spectrum
    Protection, Antioxidant-
    Rich Vitamin E & Aloe
    Soothe & Nourish

    REEF
    SAFE

    clean
    label
    PROJECT®
    CERTIFIED

    2.3 fl oz/68 mL

    SAME FORMULA
    NEW
    LOOK

    PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 UNSCENTED   PROTECT
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-061
    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)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Allantoin (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetearyl Glucoside (UNII: 09FUA47KNA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Isononyl Isononanoate (UNII: S4V5BS6GCX)  
    Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Squalane (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q)  
    Tropolone (UNII: 7L6DL16P1T)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-061-681 in 1 BOX03/01/2020
    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 FINALpart35203/01/2020
    Labeler - French Transit, Ltd. (100044380)
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