Label: KEEP THE PEACE PROTECT AND CORRECT- titanium dioxide and 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 January 24, 2011

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

View All Sections
  • ACTIVE INGREDIENT

    TITANIUM DIOXIDE......4.8%

    ZINC OXIDE..........3.0%

  • INACTIVE INGREDIENT

    CYCLOPENTASILOXANE, DIMETHICONE CROSSPOLYMER, C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, BEHENOXY DIMETHICONE, PHYTOSTEROLS, TOCOTRIENOLS, TOCOPHEROL, ORYZA SATIVA (RICE) BRAN WAX, SQUALENE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, GLYCINE SOJA (SOYBEAN) STEROLS, DIMETHICONE, CETEARYL METHICONE, LINOLEIC ACID, PHOSPHOLIPIDS, POLYHYDROXYSTEARIC ACID, BISABOLOL, CAPYLYL GLYCOL, SIMETHICONE, ALUMINA, PHENOXYETHANOL, TRIETHOXYCAPRYLYLSILANE, IRON OXIDES (CI 77491, 77492, 77499).

  • PURPOSE

    Sunscreen



    Uses: helps prevent suburn

    higher SPF gives more sunburn protection

  • WARNINGS

    FOR EXTERNAL USE ONLY.

  • WHEN USING

    WHEN USING THIS PRODUCT. 

    KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE

  • ASK DOCTOR

    STOP USE AND ASK DOCTOR IF A RASH OR IRRITATION DEVELOPS AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • QUESTIONS

    QUESTIONS?  CALL - 1-800-568-3515

  • PRINCIPAL DISPLAY PANEL

    MM1

  • INGREDIENTS AND APPEARANCE
    KEEP THE PEACE PROTECT AND CORRECT 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50184-6600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.88 mL  in 60 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE1.8 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    RICE BRAN (UNII: R60QEP13IC)  
    SQUALENE (UNII: 7QWM220FJH)  
    ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OCTYLTRIETHOXYSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50184-6600-160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/24/2011
    Labeler - Philosophy, Inc. (948102256)
    Establishment
    NameAddressID/FEIBusiness Operations
    Philosophy Inc for BioTech Research Labs948102256manufacture
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!