BULLFROG LAND SPORT SPF 50 LIP BALM- avobenzone, octisalate, octocrylene and oxybenzone stick 
SolSkyn Personal Care LLC

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.

----------

BullFrog Land Sport Lip SPF50

BullFrog Land Sport SPF 50 Lip Balm

Active Ingredients

Avobenzone 2%, Octisalate 4%, Octocrylene 10%, Oxybenzone 6%

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

• Do not use

on damaged or broken skin.

• When using this product

keep out of eyes. Rinse with water to remove.

• 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

• re-apply:

      • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:

      • limit time in the sun, especially from 10 a.m.-2 p.m.

      • wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

• for use on skin only. Avoid contact with fabric

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Butylated Hydroxytolulene, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cyclomethicone, Diisobutyl Adipate, Dimethicone, Ethylhexyl Palmitate, Flavor, Glycine Soja (Soybean) Oil, Isostearyl Linoleate, Menthol, Ozokerite, Persea Gratissima (Avocado) Oil, Propylparaben, Saccharin, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl (Vitamin E) Acetate

Questions or comments?

www.bullfrogsunscreen.com or call 1-800-715-3485 (USA)

PRINCIPAL DISPLAY PANEL

Bull Frog
Sunscreen
LAND SPORT
Lip Balm
SPF 50

PRINCIPAL DISPLAY PANEL
Bull Frog
Sunscreen
LAND SPORT
Lip Balm
SPF 50

BULLFROG LAND SPORT SPF 50 LIP BALM 
avobenzone, octisalate, octocrylene and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-339
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM, OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y, OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SOYBEAN OIL (UNII: 241ATL177A)  
ISOSTEARYL LINOLEATE (UNII: 4778M3HR0N)  
MENTHOL (UNII: L7T10EIP3A)  
CERESIN (UNII: Q1LS2UJO3A)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SACCHARIN (UNII: FST467XS7D)  
JOJOBA OIL (UNII: 724GKU717M)  
COCOA BUTTER (UNII: 512OYT1CRR)  
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70281-339-034.25 g in 1 CONTAINER; Type 0: Not a Combination Product09/15/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/15/2015
Labeler - SolSkyn Personal Care LLC (080010329)

Revised: 8/2017
Document Id: ec345c44-c3af-4a95-bf7d-5d0eee3d8687
Set id: 9aee5f78-5aa8-4e28-ad5f-132c097457ff
Version: 1
Effective Time: 20170816
 
SolSkyn Personal Care LLC