Label: COTZ SPF 58- titanium dioxide, 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 August 4, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients

    Titanium Dioxide 10%

    Zinc Oxide 3%

  • Purpose

    Sunscreen

    Sunscreen

    Uses: Helps prevent sunburn

    • Retains SPF up to 40 minutes of water immersion or perspiring

    Warnings: For external use only

    • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
    • Do not use if sensitive to ingredients • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
    • For use on children less than 6 months of age, consult a doctor.
    • Keep this and all medicines out of reach of children
    • If swallowed, get medical help or contact a Poison Control Center

    Directions: Apply generously and uniformly to all exposed skin areas before exposure to sunlight

    • Continure to rub in until fading occurs, especially in hair bearing areas
    • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.

    Other Information Sun Alert: limiting sun expusure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. May stain some fabric.

  • Inactive Ingredients

    Acrylates C10-30 Alkyl

    Acrylates Crosspolymer,

    Butylene Glycol, Butyloctyl

    Salicylate, Butylparaben,

    Capric/Caprylic Triglyceride,

    Cetearyl Alcohol, Cetearyl

    Glucoside, Cyclomethicone,

    Dimethicone, EDTA,

    Ethylhexyl Hydroxystearate

    Benzoate, Glyceryl Stearate,

    Iron Oxides, Isobutylparaben,

    Isopropylparaben,

    Melissa Officinalis (Balm

    Mint) Extract, Octyldodecyl

    Neopentanoate, PEG-100

    Stearate, Phenoxyethanol,

    Retinyl Palmitate,

    Simethicone, Sorbitan

    Laurate, Styrene/Acrylates

    Copolymer, Talc, Tocopherol,

    Tocopheryl Acetate,

    Tricontanyl PVP, Water,

    Xanthan Gum

  • UVA - Same Everyday

    UVA radiation, unlike UVB, is consistently the same all day long, all month long and all year long. UVA rays present almost the same damaging effects to the skin in December at 9 am, as they do in July at 4 pm. UVA radiation is consistently damaging, and in fact, enters deeper into the skin than UVB. Since UVA damage is cumulative and penetrates through glass, everyone requires daily, year round protection.

    • Extra gentle - no chemical sunscreen filters
    • Dries clear
    • Oil & PABA free
    • Fragrance free

    Manufactured exclusively for:
    Fallien,     West Norriton, PA 19403
    www.totalblock.com

    Made in USA

  • Principal Display Panel

    Principal Display Panel – Carton Label

    NDC 58892-910-87

    Dermatologist Recommended for Sensitive Skin

    FALLENE CoTZ®

    Contains Only Titanium & Zinc®

    WATER-RESISTANT SUN PROTECTION

    UVA-UVB SPF 58

    Net Wt. 2.5 Oz./ 70 g

    Figure
  • INGREDIENTS AND APPEARANCE
    COTZ SPF 58   SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-910
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide100 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Carbomer Copolymer Type B (UNII: 1G56KV7BUJ)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Isopropylparaben (UNII: A6EOX47QK0)  
    Lemon Balm Oil (UNII: MJ76269K9S)  
    Octyldodecyl Neopentanoate (UNII: X8725R883T)  
    Polyoxyl 100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
    Talc (UNII: 7SEV7J4R1U)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-910-871 in 1 CARTON
    170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2004
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE, PACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!