Label: TOTAL PROTECTOR COLOR 30 MEDIUM TINT- octinoxate 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 May 25, 2011

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient                        Purpose

    Zinc Oxide  - 7.8%                     Sunscreen
    Octinoxote  - 7.5%                     Sunscreen
    Octisalate   - 4.0%                     Sunscreen

  • INDICATIONS & USAGE

    When using this product do not use in or near the eyes. If product gets into eyes, rinse thoroughly with water.

  • WARNINGS

    Warnings For external use only.

  • STOP USE

    Stop use and ask a doctor if Irritation of rash appears and lasts.
  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Polson Control Center right away .
  • INACTIVE INGREDIENT

    Inactive ingredients Purified Waler (Aqua), C 12-15 Alkyl Benzoate,  Glyceryl Stearate, Glycerin,Steareth-2, Steareth-100, TricontanylPVP, PEG-100 Stearate, Tocopheryl Acetate,  Allantoin, Dimethicone, Xanthan Gum, Cetyl Hydroxyethylcellulose, Disodium EDTA, Diazolidinyl Urea, Iodopropynl Butylcarbamate, Phenoxyethanol, Methylparaben, Propylparaben, Mica(CI 77019), Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77489)
  • PURPOSE

    Active Ingredient                        Purpose

    Zinc Oxide  - 7.8%                     Sunscreen
    Octinoxote  - 7.5%                     Sunscreen
    Octisalate   - 4.0%                     Sunscreen
  • DOSAGE & ADMINISTRATION

    Directions Children under 2 years of age should use sunscreen products with a minimum SPF of 4. Adults and children 6 months and over; apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying. Children under 6 months ask a doctor.
  • PRINCIPAL DISPLAY PANEL

    Unit Carton
    Label
  • INGREDIENTS AND APPEARANCE
    TOTAL PROTECTOR COLOR 30 MEDIUM TINT 
    octinoxate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.8 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate4.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Allantoin (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    Methylparaben (UNII: A2I8C7HI9T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Steareth-2 (UNII: V56DFE46J5)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Mica (UNII: V8A1AW0880)  
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66078-504-2542 in 1 CASE
    11 in 1 CARTON
    181 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/28/2005
    Labeler - MD Formulation (087008363)
    Registrant - Harmony Labs, Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack
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!