Label: SPF 30 SUNSCREEN- octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension

  • 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 December 26, 2019

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

View All Sections
  • Drug Facts

  • Active Ingredients

    Octinoxate 7.5%,

    Octisalate 5.0%,

    Oxybenzone 2.0% 

    Titanium Dioxide 2.5%

    Soybean oil 3%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn

  • WARNINGS:

    Skin Cancer/Skin Aging Alert: Spending time in the sun increase your risk of skin cancer and early skin aging.
    This products has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only.

    Do not use

    on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor

    if rash occurs.

    Keep out of reach of children.

    If product swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply generously & evenly before sun exposure.Reapply as needed or after towel drying, swimming, or sweating. Ask doctor before using on children under 6 months.

  • Other information

    Protect this product from excessive heat and direct sun

  • Insect Repellent Active Ingredient: Soybean oil 3% Inactive ingredients

    Water, Microcrystalline cellulose, C12-15 Alkyl Benzoate, Isooctyl Palmitate, Propylene Glycol, Glyceryl Stearate Citrate, Disodium EDTA, Iodopropynyl Butylcarbamate, DMDM Hydantoin, Fragrance.

  • Drug Questions:

    877-254-2281

  • Distributed By:

    Tekweld: 45 Rabro Drive, Hauppauge, NY11788

  • Package Labeling:

    Label5

  • INGREDIENTS AND APPEARANCE
    SPF 30 SUNSCREEN 
    octinoxate, octisalate, oxybenzone, titanium dioxide spray, suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71160-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE20 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOCETYL PALMITATE (UNII: 355356620Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71160-011-0010 mL in 1 BOTTLE; Type 0: Not a Combination Product07/22/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/22/2017
    Labeler - Tekweld Solutions, Inc. (029077754)
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!