Label: ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN- spf50 cream

  • NDC Code(s): 84803-106-01, 84803-106-02
  • Packager: Grace And Fire USA Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2024

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

  • Active Ingredients

    ZINC OXIDE 22.75%

  • Purpose

    Sunscreen

  • Uses

    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 doctor if

    - rash occur

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    if swallowed , call a poison control centre or get medical help right away

  • Directions

    Directions
     Apply liberally 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 a Broad-Spectrum SPF value of
    15 or higher and other sun protection
    measures including:  Limit time in
    the sun, especially from 10a.m.–
    2p.m.  Wear long-sleeved shirts,
    pants, hats, and sunglasses
     Children under 6 months of age:
    Ask a doctor

  • Inactive Ingredients

    Inactive Ingredients
    Water, Coco-Caprylate/Caprate,
    Octyldodecanol, Caprylic/Capric
    Triglyceride, PEG-30
    Dipolyhydroxystearate, Glycerin,
    Polyglyceryl-3 Polyricinoleate,
    Cetearyl Glucoside, Cetearyl Alcohol,
    Gluconolactone, Isostearic Acid,
    Sodium Chloride, Saccharide
    Isomerate, Sodium Benzoate,
    Xanthan Gum, Disodium EDTA,
    Terminalia Ferdinandiana (Kakadu
    Plum) Fruit Extract, Calcium
    Gluconate, Citric Acid, Ammonium
    Acryloyldimethyltaurate/VP
    Copolymer, Sodium Citrate, Iron
    Oxides (CI77492), Iron Oxides
    (CI77491), Iron Oxides (CI77499).

  • Other Information

    Protect this product from excessive heat and direct sun

    Broad Spectrum SPF 50
    Sunscreen PA++++
    15ml

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN 
    spf50 cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84803-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CI 77499 (UNII: XM0M87F357)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    CI 77492 (UNII: EX438O2MRT)  
    WATER (UNII: 059QF0KO0R)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CI 77491 (UNII: 1K09F3G675)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    2-ACETAMIDO-2-DEOXY-D-GLUCONO-1,5-LACTONE (UNII: 09ICI1V6AX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84803-106-0250 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2024
    2NDC:84803-106-0115 mL in 1 TUBE; Type 0: Not a Combination Product12/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2024
    Labeler - Grace And Fire USA Inc. (119357605)
    Registrant - Grace And Fire USA Inc. (119357605)