Label: PANOXYL OIL CONTROL MOISTURIZER- titanium dioxide and zinc oxide lotion

  • 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 October 19, 2021

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

  • Active Ingredients

    Titanium Dioxide - 1.0%

    Zinc Oxide - 7.8%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn and photodamage caused by UVA/UVB exposure
    • Higher SPF gives more sunburn protection
    • If used as directed with other sun protection measures (see Directions), decreases the risks of skin cancer and early skin aging caused by the sun
  • Warnings

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

    • Stop use and ask doctor if rash or irritation occurs

    Do not use: • On damaged or broken skin • If allergic to any ingredient

    • If swallowed, get medical help or contact a Poison Control Center

  • Directions

    Shake well prior to use

    • Apply liberally to dry skin 15 minutes before sun exposure

    • For topical use only

    • Keep out of reach of children • 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 10 a.m. - 2 p.m.

    • Wear long-sleeved shirts, pants, hats, and sunglasses.

    Reapply to dry skin: • At least every 2 hours • Use a water resistant suscreen if swimming for sweating

  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • May stain some fabrics
  • Inactive Ingredients

    Alumina, Aluminum Starch Octenylsucciante, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caffeine, Camellia Sinensis Leaf (Green Tea) Extract, Caprylyl Glycol, Chlorphenesin, Cyclomethicone, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Isostearyl Alcohol, Laureth-7, Lauryl PEG/PPG 18/18 Methicone, Phenoxyethanol, Polyacrylamide, Polyhydroxystearic Acid, Purified Water, Sodium Hyaluronate, Triethoxycaprylylsilane

  • Questions ?

    Call 800.877.8869

    or visit www.panoxyl.com

    Crown Laboratories, Inc., Johnson City, TN 37604

    Made in USA

  • PanOxyl Oil Control Moisturizer 1.7oz Tube

    DERMATOLOGIST RECOMMENDED

    PanOxyl AM

    OIL CONTROL MOISTURIZER

    Broad Spectrum SPF 30

    Mineral Sunscreen

    Lightweight Daily Moisturizer

    Absorbs Excess Oil

    UVA/UVB Protection

    Won't Clog Pores

    P11833.00

    panoxyloilcontrolam

  • PanOxyl Oil Control Moisturizer 1.7oz Carton

    New

    DERMATOLOGIST RECOMMENDED

    PanOxyl AM

    OIL CONTROL MOISTURIZER

    Broad Spectrum SPF 30

    Mineral Sunscreen

    Lightweight Daily Moisturizer

    Absorbs Excess Oil

    UVA/UVB Protection

    Won't Clog Pores

    P11834.01

    panoxylocmcarton

  • INGREDIENTS AND APPEARANCE
    PANOXYL OIL CONTROL MOISTURIZER 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0263
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE83.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAFFEINE (UNII: 3G6A5W338E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0263-021 in 1 CARTON03/09/2021
    148 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 finalpart35203/09/2021
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-0263)