Label: ATTITUDE KIDS MINERAL SUNSCREEN UNSCENTED SPF 30- zinc oxide cream

  • NDC Code(s): 61649-160-15, 61649-160-75
  • Packager: 9055-7588 Québec 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 or medicinal ingredient

    Zinc oxide (20%)

  • Purpose

    Sunscreen

  • Use

    Helps prevent sunburn

  • Warnings

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

    Do not use on broken skin.

    Stop use and ask a doctor ifrash occurs.

    When using this product keep out of 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.

  • Directions

    Adults and children older than 6 months.

    • Apply generously 15 minutes prior to sun exposure.
    • Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing .

    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: [Bullet] limit time in the sun, especially from 10 a.m.-2 p.m. 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 - 75 g Tube Label

    ATTITUDE ®
    natural care

    30
    SPF
    SUNLY

    unscented

    broad spectrum SPF 30

    UVA UVB + NON NANO

    VEGAN

    Dermatologically tested

    EWG verified

    NPN 80047088 ∙ 75 g / 2.6 OZ.

    Label

  • INGREDIENTS AND APPEARANCE
    ATTITUDE KIDS MINERAL SUNSCREEN UNSCENTED SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61649-160
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61649-160-7575 g in 1 TUBE; Type 0: Not a Combination Product11/24/2023
    2NDC:61649-160-15150 g in 1 TUBE; Type 0: Not a Combination Product11/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/24/2023
    Labeler - 9055-7588 Québec Inc. DBA Attitude (201137051)
    Establishment
    NameAddressID/FEIBusiness Operations
    9055-7588 Québec Inc. DBA Attitude204307099manufacture(61649-160) , label(61649-160) , pack(61649-160) , analysis(61649-160)
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