Label: MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY SPF 50 PROTECT- zinc oxide 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 Ingredient

    Zinc Oxide 21%

  • Purpose

    Sunscreen

  • 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.
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply: After 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • 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

    Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water

  • Other Information

    • Protect this product from excessive heat and direct sun.
    • May stain some fabrics
  • PRINCIPAL DISPLAY PANEL - 177 mL Tube Label

    MyCHELLE®
    DERMACEUTICALS

    PROTECT

    Replenishing Solar
    Defense Body Lotion
    SPF 50 Water Resistant

    Broad-spectrum Protection,
    Coconut Oil & Shea Butter
    Moisturize & Soothe

    REEF
    SAFE

    SAME FORMULA
    NEW LOOK

    clean
    label
    PROJECT®
    CERTIFIED

    6.0 fl oz/177 mL

    Principal Display Panel - 177 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY SPF 50   PROTECT
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide21 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Coco Glucoside (UNII: ICS790225B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Diheptyl Succinate (UNII: 057N7SS26Y)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    Sodium Gluconate (UNII: R6Q3791S76)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    Tocopherol (UNII: R0ZB2556P8)  
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
    Vanillin (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-021-68177 mL in 1 TUBE; Type 0: Not a Combination Product03/01/2020
    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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