EXPEDITION BACKCOUNTRY SPF 30- octocrylene, octisalate, and avobenzone spray

Expedition BackCountry SPF 30 by

Drug Labeling and Warnings

Expedition BackCountry SPF 30 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 5.0%

Octisalate 3.0%

Avobenzone 2.5%

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, citronella oil, eucalyptus oil, fir needle oil, lavandin oil, litsea oil, camphor oil, patchouli oil, yara yara, and orange oil.

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: 52854-326-01

INGREDIENTS AND APPEARANCE

EXPEDITION BACKCOUNTRY SPF 30 
octocrylene, octisalate, and avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52854-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ABIES BALSAMEA LEAF OIL (UNII: 2FGT9T2SQC)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ACHILLEA MILLEFOLIUM ROOT OIL (UNII: 0S45F449MJ)
LITSEA OIL (UNII: 2XIW34BN6O)
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)
CITRONELLA OIL (UNII: QYO8Q067D0)
POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)
LAVANDIN OIL (UNII: 9RES347CKG)
CAMPHOR OIL (UNII: 75IZZ8Y727)
ORANGE OIL (UNII: AKN3KSD11B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52854-326-01	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(52854-326)