Label: COTZ MINERAL SUNS STICK - TINTED SPF 45- titanium dioxide, zinc oxide stick

  • NDC Code(s): 58892-349-01
  • Packager: Fallien Cosmeceuticals, LTD
  • Category: HUMAN OTC DRUG LABEL

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 August 15, 2022

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  • Active Ingredients

    Titanium Dioxide 4.0%

    Zinc Oxide 5.5%

  • Purpose

    Sunscreen

    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. Stop use and ask a doctor if rash occurs. 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:

    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: 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 10am-2pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Inactive Ingredients:

    Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Ethylene Brassylate, Helianthus Annuus (Sunflower), Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics

    Manufactured Exclusively For:

    CoTZ® Skincare

    Norristown, PA 19403

    www.cotzskincare.com

  • Principal Display Panel – Carton Label

    CoTZ®

    the HEALTHIER SUNSCREEN®

    Mineral Sun Stick

    Tinted

    SPF
    45

    SHEER

    MINERAL SUNSCREEN

    FACE & BODY

    SPF 45 Broad Spectrum

    Water Resistant (80 Minutes)

    Net Wt. 1 oz./30 g.

    Principal Display Panel – Carton Label
  • INGREDIENTS AND APPEARANCE
    COTZ MINERAL SUNS STICK - TINTED SPF 45 
    titanium dioxide, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-349
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide55 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    CERESIN (UNII: Q1LS2UJO3A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-349-011 in 1 CARTON04/01/2022
    130 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2022
    Labeler - Fallien Cosmeceuticals, LTD (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-349)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-349) , PACK(58892-349) , LABEL(58892-349)
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