Label: ATTITUDE MINERAL SUNSCREEN LITTLE ONES - FRAGRANCE FREE- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 9, 2017

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active ingredient

    Zinc oxide (20%)

  • 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. If rash occurs, stop use and ask a octor.

    When using this product keep out of eyes. Rinse with water to remove.

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

  • Directions

    -
    Apply liberally 15 minutes before sun exposure
    -
    Reapply:
    -
    At least every 2 hours
    -
    After 40 minutes of swimming or sweathing
    -
    Immediately after towel drying
    -
    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 10am–2pm
    -
    Wear long-sleeved shirts, pants, hats, and sunglasses
    -
    Ask a doctor for use on children under 6 months of age.
  • Inactive ingredients

    Aqua, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, glyceryl isostearate, glyceryl stearate, C10-18 triglycerides, glycerin, polyhydroxystearic acid, ethylhexylglycerin, caprylyl glycol, xanthan gum, sodium gluconate.

  • Other Information

    Store at temperatures below 90oF.

  • PRINCIPAL DISPLAY PANEL - 75 g Tube Label

    BIO SPECTRA
    ATTITUDE®

    little ones

    30
    SPF

    100% MINERAL
    SUNSCREEN
    fragrance-free • hypoallergenic
    BROAD SPECTRUM (UVA/UVB), NON NANO
    DERMATOLOGICALLY TESTED

    • EWG VERIFIED • FOR YOUR HEALTH • EWG.ORG™

    WORRY-FREE
    • INGREDIENTS •

    NPN 80047088 • 75 g / 2.6 OZ.

    PRINCIPAL DISPLAY PANEL - 75 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ATTITUDE   MINERAL SUNSCREEN LITTLE ONES - FRAGRANCE FREE
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-001
    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)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-001-751 in 1 CARTON03/01/2014
    175 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:61649-001-151 in 1 CARTON03/01/2014
    2150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/01/2014
    Labeler - Bio Spectra (201137051)
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