Label: BIO SPECTRA ATTITUDE- zinc oxide cream

  • NDC Code(s): 61649-110-15
  • Packager: 9055-7588 Quebec Inc. DBA Attitude
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 1, 2024

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Zinc oxide (20%)

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    Allergens: soybeans (glycerin). For external use only.

    Do not use on broken skin.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

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

    Stop use and consult a doctor if rash occurs.

  • Directions

    Adults and children older than 6 months.

    • Apply generously 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor.
  • Inactive or non-medicinal ingredients

    Aqua / Water / Eau, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Glyceryl Stearate, Cetearyl Alcohol, Polyhydroxystearic Acid, C10-18 Triglycerides, Glycerin, Ethylhexylglycerin, Caprylyl Glycol, Behenyl Alcohol, Sodium Chloride, Xanthan Gum, Sodium Gluconate.

  • Other Information

    Store at temperatures below 90°F and protect from direct sun.

  • QUESTIONS

    Questions ? 1-855-509-7225

  • PRINCIPAL DISPLAY PANEL - 150 g Tube Label

    ATTITUDE ®
    natural care

    SPF 30

    Unscented

    Mineral sunscreen

    Broad spectrum SPF 30

    UVA/UVB - Non nano

    SUNLY

    VEGAN

    Dermatologically tested

    EWG Verified

    NPN 80047088 • 150 g e / 5.2 OZ.

    Label

  • INGREDIENTS AND APPEARANCE
    BIO SPECTRA  ATTITUDE
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    Product Characteristics
    Colorwhite (Opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-110-15150 g in 1 TUBE; Type 0: Not a Combination Product12/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/11/2023
    Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    9055-7588 Quebec Inc. DBA Attitude204307099manufacture(61649-110) , label(61649-110) , pack(61649-110) , analysis(61649-110)
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