Label: NENA MINERAL SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream

  • NDC Code(s): 52311-686-01
  • Packager: Ironwood Clay Company Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 5, 2024

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  • Inactive ingredients:

    Aloe Barbadensis Leaf Extract
    Aloe Barbadensis Leaf Juice
    Alumina
    Arachidyl Alcohol
    Arachidyl Glucoside
    Behenyl Alcohol
    Benzyl Alcohol
    Brassica Campestris/Aleurites Fordi Oil Copolymer
    Calendula Officinalis Flower Extract
    Camellia Sinensis Leaf Extract
    Caprylic/Capric Triglyceride
    Chromium Oxide Greens
    Glycerin
    Glyceryl Stearate SE
    Helianthus Annuus (Sunflower) Seed Oil
    Jojoba Esters
    Myristyl Alcohol
    Myristyl Glucoside
    Propanediol
    Salicylic Acid
    Sea Silt
    Sea Silt Extract
    Sorbic Acid
    Stearyl Alcohol,
    Tocopherols
    Tridecane
    Undecane
    Xanthan Gum

  • 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. If swallowed, call a poison control centre or get medical help right away

  • Directions

    Apply liberally and evenly 15 minutes before sun exposure.
    Reapply at least every 2 hours.
    Children under 6 months of age: Ask a doctor.
    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 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

    Use a water resistant sunscreen if swimming or sweating.

  • Drug Facts

    Active ingredients (in each dosage unit) Purpose

    Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen

    Zinc oxide 22% .…………………….………………………………………………………. Sunscreen

  • Uses

    Helps prevent sunburn.

    Helps protect from sunburn.
    If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun.
    Sun Protection Factor 30 / SPF 30.

  • Questions?

    Email contact@nenaskincare.com

  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • DOSAGE & ADMINISTRATION

    Dosage: Cream

    Route of adminstration: Topical

  • INDICATIONS & USAGE

    See "Uses" and "Warnings"

  • KEEP OUT OF REACH OF CHILDREN

    Refer to "Keep out of reach of children" in "Warnings" section

  • PRINCIPAL DISPLAY PANEL

    NENA Mineral Sunscreen SPF 30

  • INGREDIENTS AND APPEARANCE
    NENA MINERAL SUNSCREEN SPF 30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52311-686
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.3 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROGENATED JOJOBA OIL (UNII: 7F674YQ5SO)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MYRISTYL GLUCOSIDE (UNII: 6AK28695LF)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    UNDECANE (UNII: JV0QT00NUE)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SORBIC ACID (UNII: X045WJ989B)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    TRIDECANE (UNII: A3LZF0L939)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CHROMIC OXIDE (UNII: X5Z09SU859)  
    BRASSICA RAPA SUBSP. OLEIFERA WHOLE (UNII: B0MET6L3EC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52311-686-011 in 1 BOX06/17/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/17/2024
    Labeler - Ironwood Clay Company Inc. (248997694)
    Registrant - Ironwood Clay Company Inc. (248997694)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ironwood Clay Company Inc.248997694manufacture(52311-686)
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