Label: BURN OUT SPF-30 SUNSCREEN- zinc oxide 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 January 21, 2020

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Zinc Oxide (non-nano) 20%

  • Purpose

    sunscreen

  • Use(s)

    • Provides high protection against sunburn.
    • Provides broad spectrum (UVA and UVB) protection.
    • Retains SPF after 40 minutes of activity in the water or sweating.
    • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only.

    When using this product

    • Keep out of eyes. Rinse with water to remove.
    • Stop and ask a doctor if rash or irritation occurs.

    Keep out of reach of children.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      • After 40 minutes of swimming or sweating
      • Immediately after towel drying
      • At least every 2 hours
    • Children under 6 months: Ask a doctor
  • Inactive Ingredients

    Purified Water, Organic Aloe Barbadensis Leaf Juice1, Capric/ Caprylic Triglycerides, Sorbitan Stearate, Polyglyceryl-10 Laurate, Cetyl Dimethicone, Magnesium Sulfate, Organic Avocado Oil1, Virgin Hemp Seed Oil, Organic Cucumber Extract1, Organic Green Tea Extract1, Tocopherols, Organic Pomegranate Juice1, Helionori, Hyaluronic Acid, Ethylhexylglycerin, Hydrogenated Methyl Abiate, Polyaminopropyl Biguanide.

    1
    Certified by a USDA third party agency
  • Other Information

    High sun protection product.

  • Questions?

    Call toll free 1-800-798-7970

  • PRINCIPAL DISPLAY PANEL - 100 ml Tube Label

    Burn Out®

    BROAD SPECTRUM
    SPF 30

    OCEAN TESTED
    PHYSICAL
    SUNSCREEN

    No Nanoparticles
    Petroleum-free, Paraben-free

    Enriched with Antioxidants,
    Organic Avocado Oil & Helionori

    Water Resistant (40 min)

    PRINCIPAL DISPLAY PANEL - 100 ml Tube Label
  • INGREDIENTS AND APPEARANCE
    BURN OUT SPF-30 SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55777-0100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    TRICAPRILIN (UNII: 6P92858988)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    polyglyceryl-10 laurate (UNII: MPJ2Q8WI8G)  
    cetyl dimethicone 150 (UNII: 5L694Y0T22)  
    magnesium sulfate, unspecified form (UNII: DE08037SAB)  
    avocado oil (UNII: 6VNO72PFC1)  
    cannabis sativa seed oil (UNII: 69VJ1LPN1S)  
    green tea leaf (UNII: W2ZU1RY8B0)  
    tocopherol (UNII: R0ZB2556P8)  
    pomegranate juice (UNII: 99S671U9KB)  
    hyaluronic acid (UNII: S270N0TRQY)  
    ethylhexylglycerin (UNII: 147D247K3P)  
    hydrogenated methyl abietate (UNII: A23O709X8O)  
    polihexanide (UNII: 322U039GMF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55777-0100-1100 mL in 1 TUBE; Type 0: Not a Combination Product09/12/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35209/12/2013
    Labeler - Sun Research LLC (031405272)
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!