LAND SHARK SPF 50- octocrylene, octisalate, and avobenzone spray

Land Shark SPF 50 by

Drug Labeling and Warnings

Land Shark SPF 50 by is a Otc medication manufactured, distributed, or labeled by Tropical Seas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Octocrylene 10.0%

Octisalate 5.0%

Avobenzone 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable: Do not use near heat, flame, or while smoking

Do not use on damaged or broken skin

When using this product:

• Keep out of eyes. Rinse with water to remove.
• Do not puncture or incinerate. Contents under pressure.
• Do not store at temperatures above 120° F

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• do not spray directly on face - spray into hands and apply to face
• hold approximately 4 - 6 inches from skin to spray
• rub into skin evenly to ensure appropriate coverage
• use in a well-ventilated area
• avoid inhaling or exposing others to spray
• do not apply in windy conditions
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

sd alcohol 40-b, deionized water, lauryl lactate, cyclopentasiloxane, c12-15 alcohols benzoate, acrylates octylacrylamide copolymer, octyldodecyl neopentanoate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, and fragrance.

Other Information

• protect this product from excessive cold, heat, and direct sun.
• store at temp below 90º F and avoid long term storage
• may stain fabrics or surfaces

Questions or comments?

Call toll free 1-800-368-7327

Principal Display Panel - Bottle Label

180ml NDC: 52854-951-01

INGREDIENTS AND APPEARANCE

LAND SHARK SPF 50 
octocrylene, octisalate, and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-951
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENETHYL BENZOATE (UNII: 0C143929GK)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LAURYL LACTATE (UNII: G5SU0BFK7O)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: X323T6QO4M)
ALCOHOL (UNII: 3K9958V90M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-951-01	180 mL in 1 CAN; Type 0: Not a Combination Product	12/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/07/2020

Labeler - Tropical Seas, Inc. (627865660)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Seas, Inc.		627865660	manufacture(52854-951)