BURN OUT SPF-30 SUNSCREEN- zinc oxide lotion

Burn Out SPF-30 Sunscreen by

Drug Labeling and Warnings

Burn Out SPF-30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Sun Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

BURN OUT SPF-30 SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55777-0100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	20 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55777-0100-1	100 mL in 1 TUBE; Type 0: Not a Combination Product	09/12/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/12/2013

Labeler - Sun Research LLC (031405272)