Label: MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR SPF 30 BROAD SPECTRUM- zinc oxide spray

  • 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

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Zinc Oxide 12%

  • 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

    Do not puncture or incinerate can. Keep away from fire and flames. 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. Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray. 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

    Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water

  • Other information

    Protect this product from excessive heat and direct sun. Store at temperatures below 90°F

    • May stain some fabrics
  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

    Continuous Spray
    Twist-lock Cap

    SUN
    PROTECTION

    Sun Shield
    Clear Spray
    SPF 30
    Broad Spectrum

    MyChelle®
    dermaceuticals

    REEF
    SAFE
    WATER
    RESISTANT

    6 fl oz / 177 mL

    Principal Display Panel - 177 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR  SPF 30 BROAD SPECTRUM
    zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Bentonite (UNII: A3N5ZCN45C)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Caprylhydroxamic Acid (UNII: UPY805K99W)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Glycerin (UNII: PDC6A3C0OX)  
    Heptyl Undecylenate (UNII: W77QUB6GXO)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    Methyl Dihydroabietate (UNII: 7666FJ0J9F)  
    Vanillin (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-040-77177 mL in 1 BOTTLE, SPRAY; 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!