EXPEDITION BACKCOUNTRY SPF 30- octocrylene, octisalate, avobenzone lipstick 
Tropical Seas, Inc.

----------

Lip Balm Unflavored SPF 30

Drug Facts

Active Ingredients

Octocrylene 5.0%

Octisalate 3.0%

Avobenzone 2.5%

Purpose

Sunscreen

Uses

Warnings

For external use only *Keep out of eyes

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

Directions

Inactive Ingredients

ricinus communis (castor) seed oil, cetearyl alcohol, lauryl laurate, olea europaea (olive) fruit oil, hydrogenated castor oil, beeswax, copernicia cerifera (carnauba) wax, flavor, hydrogenated soybean oil, euphorbia cerifera (candelilla) wax, flavor, glyceryl stearate, octyl dodecyl citrate crosspolymer, phenethyl benzoate, cocos nucifera (coconut) fruit extract, octyldodecyl neopentanoate, cetyl dimethicone, hippophae rhamnoides (sea buckthorn) oil.

Principal Display Panel - Label

4.44g NDC 52854-927-01

4.44g NDC 52854-927-01 label

4.44g NDC 52854-927-01 Blister Card Front

4.44g NDC 52854-927-01 Blister Card Front

4.44g NDC 52854-927-01 Blister Card Back

4.44g NDC 52854-927-01 Blister Card Back

EXPEDITION BACKCOUNTRY SPF 30 
octocrylene, octisalate, avobenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52854-976
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CASTOR OIL (UNII: D5340Y2I9G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LAURYL LAURATE (UNII: GPW77G0937)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
CANDELILLA WAX (UNII: WL0328HX19)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
COCONUT (UNII: 3RT3536DHY)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52854-976-014.44 g in 1 TUBE; Type 0: Not a Combination Product08/10/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/10/2023
Labeler - Tropical Seas, Inc. (627865660)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Seas, Inc.627865660manufacture(52854-976)

Revised: 10/2023
Document Id: 06d446a8-2fbd-fea1-e063-6394a90a835e
Set id: 06d43525-86d8-f2d9-e063-6394a90afc81
Version: 1
Effective Time: 20231003
 
Tropical Seas, Inc.