BULLFROG SPF50 LAND SPORT QUIK- avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

BullFrog SPF50 Land Sport Quik by

Drug Labeling and Warnings

BullFrog SPF50 Land Sport Quik 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 SPF50 Land Sport Quik Gel

Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, 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

Flammable: keep away from fire or flame.

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

Inactive Ingredients

Acacia Farnesiana Extract, Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Extract, Camellia Oleifera (Green Tea) Leaf Extract, Chamomile Flower Extract, Cyclohexasiloxane, Cyclopentasiloxane, Ethylhexyl Palmitate, Fragrance, Glycerin, Hydroxypropylcellulose, Isopropyl Myristate, Lavender Extract, Phenethyl Benzoate, PPG-12/SMDI Copolymer, Propylene Glycol, Rosemary Leaf Extract, SD Alcohol 40 (50.65% w/w), Tocopheryl (Vitamin E) Acetate

Questions or comments?

www.bullfrogsunscreen.com or call toll-free 1-800-715-3485

MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

PRINCIPAL DISPLAY PANEL

Bull
Frog
Sunscreen
Land Sport
Quick Gel
SPF 50

INGREDIENTS AND APPEARANCE

BULLFROG SPF50 LAND SPORT QUIK 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70281-338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mg
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 mg  in 100 mg
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 mg  in 100 mg
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ROSEMARY (UNII: IJ67X351P9)
ALCOHOL (UNII: 3K9958V90M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70281-338-13	147 mg in 1 BOTTLE; 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)