Label: MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY SPF 50 BROAD SPECTRUM- 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 February 22, 2019

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    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. 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
    • Children under 6 months: ask a doctor.
    • 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.
  • 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

    SUN
    PROTECTION

    Replenishing
    Solar Defense
    Body Lotion

    SPF 50

    Broad Spectrum

    ANTI-AGING

    MyChelle®
    dermaceuticals

    REEF
    SAFE
    WATER
    RESISTANT

    6 fl oz / 177 mL

    PRINCIPAL DISPLAY PANEL - 177 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE BODY   SPF 50 BROAD SPECTRUM
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-020
    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)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Glycerin (UNII: PDC6A3C0OX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Sodium Gluconate (UNII: R6Q3791S76)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Diheptyl Succinate (UNII: 057N7SS26Y)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Tocopherol (UNII: R0ZB2556P8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Coco Glucoside (UNII: ICS790225B)  
    Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
    UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Vanillin (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-020-68177 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2017
    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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