Label: MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE SPF 30 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 Ingredient

    Zinc Oxide (ZinClear™) 13.5%

  • 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

    • 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

    Alcohol, Aleurites Moluccana Seed Oil, Aqua (Water), Behenyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)

  • Other information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

    SUN
    PROTECTION

    Replenishing
    Solar Defense
    SPF 30
    Broad Spectrum

    Age Defense

    REEF
    SAFE

    MyChelle®
    dermaceuticals

    2.3 fl oz / 68 mL

    PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
  • INGREDIENTS AND APPEARANCE
    MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE   SPF 30 BROAD SPECTRUM
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72805-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide13.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isodecyl Neopentanoate (UNII: W60VYE24XC)  
    Ethyl Macadamiate (UNII: ANA2NCS6V1)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    BARLEY (UNII: 5PWM7YLI7R)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    SANDALWOOD (UNII: 3641YW25N2)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    Glyceryl Isostearate (UNII: HYE7O27HAO)  
    Sodium Stearoyl Lactylate (UNII: IN99IT31LN)  
    Polyglyceryl-10 Pentastearate (UNII: PMX5872701)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALIC ACID, L- (UNII: J3TZF807X5)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)  
    Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)  
    Alcohol (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72805-030-771 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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