BULLFROG LAND SPORT SPF 50 LIP BALM- avobenzone, octisalate, octocrylene and oxybenzone stick

BullFrog Land Sport SPF 50 Lip Balm by

Drug Labeling and Warnings

BullFrog Land Sport SPF 50 Lip Balm by is a Otc medication manufactured, distributed, or labeled by SolSkyn Personal Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BULLFROG LAND SPORT SPF 50 LIP BALM 
avobenzone, octisalate, octocrylene and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-339
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM, OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y, OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-339-03	4.25 g in 1 CONTAINER; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2015

Labeler - SolSkyn Personal Care LLC (080010329)