Label: MICRO DAY REJUVENATING BROAD-SPECTRUM SUNSCREEN SPF 30- octinoxate and zinc oxide lotion

  • NDC Code(s): 46783-173-04, 46783-173-05, 46783-173-10, 46783-173-20, view more
    46783-173-50
  • Packager: Merz North America, Inc.
  • 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 June 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.5%

    Zinc Oxide 7.3%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn and premature skin aging.
    • 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.
    • Higher SPF gives more sunburn protection.
  • 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 occurs.

    Keep out of reach of children. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    See package insert for complete information.

  • DOSAGE & ADMINISTRATION

    For sunscreen use:

    • Apply generously 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.

    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 Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10am - 2pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
    • Children under 6 months of age, ask a doctor.
  • Inactive ingredients

    Water, Caprylic/Capric Triglyceride, Hydrogenated C6-14 Olefin Polymers, Hexyldecanol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Camelia Sinensis Extract, Silica, Tetrapeptide-21, Capryloyl Carnosine, Palmitoyl Tripeptide-1 Acetate, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Squalane, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polyhydroxystearic Acid, Steareth-21, Melanin, Cetearyl Alcohol, Sodium Hyaluronate, Polysorbate 60, Triethoxycaprylsilane, Disodium EDTA, Xanthan Gum, Cellulose Gum, Styrene/Acrylates Copolymer, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

  • Other information

    • Protect this product from excessive heat and direct sun.
  • Questions?

    USA: 866.636.2884 • International: +800.1489.1489

  • SPL UNCLASSIFIED SECTION

    Distributed in the USA by Merz North America, Inc.

  • PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton

    micro day®

    REVITALIZING
    & TIGHTENING
    DAY CREAM
    SPF 30

    NEOCUTIS®

    PRINCIPAL DISPLAY PANEL - 50 ML Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MICRO DAY REJUVENATING BROAD-SPECTRUM SUNSCREEN SPF 30 
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46783-173
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE73 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-21 (UNII: 53J3F32P58)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46783-173-051 in 1 CARTON03/23/201502/28/2023
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:46783-173-101 in 1 CARTON03/23/201512/31/2022
    230 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:46783-173-201 in 1 CARTON03/23/201512/31/2022
    3200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:46783-173-044 mL in 1 TUBE; Type 0: Not a Combination Product06/15/201910/31/2024
    5NDC:46783-173-501 in 1 CARTON10/20/201912/31/2023
    550 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/23/201510/31/2024
    Labeler - Merz North America, Inc. (028147846)
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