Label: SUNTAN LOTION- octinoxate oxybenzone titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 10, 2010

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

View All Sections
  • Active Ingredient

    Octyl Methoxycinnamate 7%

    Oxybenzone 6%

    Titanium Dioxide 1%



  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • Keep out of eyes. If contact occurs, rinse thoroughly with water.

  • Stop use and ask a doctor if

    • irritation develops
  • Keep out of reach of children

    • If swallowed, get medical help promptly or contact Poison Control immediately.
  • Directions

    • Apply generously and evenly before sun exposure. Reapply as needed or after towel drying, swimming or perspiring. Ask doctor before use on children under 6 months of age
  • Inactive Ingredients

    Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cylcomethicone, DC Orange 4, Disodium EDTA, FDC Blue 1, FDC Yellow 5, Fragrance, Glycerin, Imidazolidinyl Urea, Isopropyl Myristate, Methylparaben, Potassium Cetyl Phosphate, Propylparaben, Tocopheryl Acetate, Water ( Aqua), Xanthan Gum

  • Package Label

    Package Label
    image of package label





  • INGREDIENTS AND APPEARANCE
    SUNTAN LOTION 
    octinoxate oxybenzone titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49852-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mL  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    D&C ORANGE NO. 4 (UNII: Q1LIY3BO0U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49852-201-6060 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/28/2010
    Labeler - Tri-Coastal Design Company Inc. (609734900)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou St Eva Fine Chemical Co Ltd 528039793manufacture
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!